Laparoscopic CholecystectomyNCT05636475
The Effect Of Machine-Based And Manually Applied Hand Massage On Pain, Anxiety And Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
A study testing Manual hand massage after laparoscopic cholecystectomy surgery and Machine-based hand massage after laparoscopic cholecystectomy surgery in people with Laparoscopic Cholecystectomy, run by Münevver Şengül at 1 site in Turkey (Türkiye).
Trial summary
Introduction: As after almost every surgical procedure, changes in the patient's system functions, acute pain and an increase in anxiety level occur after laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- Manual hand massage after laparoscopic cholecystectomy surgery and Machine-based hand massage after laparoscopic cholecystectomy surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and over,
- Having undergone laparoscopic cholecystectomy,
- No complications after laparoscopic cholecystectomy,
- Receiving analgesia treatment according to the clinical protocol,
- Pain score >4 according to the Numerical Rating Scale,
- Able to speak and understand Turkish
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- No visual or auditory problems,
- No diagnosed psychiatric problem,
- No diagnosed gastrointestinal problem,
- Voluntary patients will be included.
Who cannot join
- Having undergone open cholecystectomy,
- Complications after laparoscopic cholecystectomy,
- Pain score ≤4 according to the Numerical Rating Scale,
- Using analgesic drugs or methods other than clinical protocol,
- Having visual or auditory problems,
- Having a diagnosed psychiatric problem,
Show all 9Show fewer
- Diagnosed gastrointestinal problem,
- Patients with contagious skin disease (such as zoster, fungus, wart, eczema) on their hands, presence of thrombosis or phlebitis, any fracture, ligament injury,
- Non-voluntary patients will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Introduction: As after almost every surgical procedure, changes in the patient's system functions, acute pain and an increase in anxiety level occur after laparoscopic cholecystectomy. Uncontrolled pain and anxiety slows down the healing process, increases the possibility of opioid use and the risk of undesirable side effects, and increases mortality, and prolongs hospital discharge.
Objective: The aim of the thesis study is to evaluate the effect of machine-based and manual hand massage applied in the postoperative period on pain, anxiety and gastrointestinal system functions in patients who have undergone laparoscopic cholecystectomy.
Method: In the study planned as a randomized controlled experimental study; There will be 3 groups, 57 patients in each group, including the experimental groups and the control group, who have undergone laparoscopic cholecystectomy and hospitalized in the General Surgery Clinic of Bartın State Hospital, where machine-based and manual hand massage will be applied. In addition to the analgesic treatment requested by the physician at the 0th, 4th and 8th hours after the surgery, the experimental groups will be given 10 minutes of hand massage to each hand, and only the requested treatment will be applied to the control group. After the applications, the changes in the pain and anxiety levels of the patients as well as the effects on the gastrointestinal system functions will be recorded. 'Data Collection Form', 'Numerical Rating Scale', 'State-Trait Anxiety Scale' and 'Gastrointestinal functions monitoring form' will be used to collect the data and the data will be analyzed in SPSS 22.0 program.
Read the detailed description
As with almost every surgical procedure, changes in the patient's system functions, acute pain and an increase in anxiety level occur after laparoscopic cholecystectomy. Uncontrolled pain and anxiety slows down the healing process, increases the possibility of opioid use and the risk of undesirable side effects, and increases mortality, and prolongs hospital discharge. Massage; increases patient comfort, relaxation and satisfaction and reduces stress. Receptors associated with nerve fibers that transmit pain to the brain are mostly found in the feet and hands. For this reason, the effect of hand massage was wanted to be examined.
The aim of the thesis study is to evaluate the effect of manual and machine-based application of hand massage on pain, anxiety and GIS functions after laparoscopic cholecystectomy. In the study planned as a randomized controlled experimental study; There will be 3 groups, 57 patients in each group, including the experimental groups and the control group, who have undergone laparoscopic cholecystectomy and hospitalized in the General Surgery Clinic of Bartın State Hospital, where machine-based and manual hand massage will be applied.
First, the researcher will receive certified training on hand massage. Necessary permissions will be obtained to carry out the research. Patients who have undergone laparoscopic cholecystectomy in the general surgery service of Bartın state hospital and meet the inclusion criteria will be divided into 3 groups, 2 experimental and 1 control group, by block randomization. Before starting the application, the purpose of the research will be explained by the researcher and the informed consent of the individuals will be obtained. Data will be collected between September 2022 and June 2023. The patient will fill in the 'Section 1 of the Data Collection Form' and the 'Trait Anxiety Scale' at least 1 hour before the surgery in the preoperative period. The second part will be filled at the most appropriate time after the surgery. When the patient comes to the service after the surgery, before the first hour is up, that is, at the 0th hour and at the 4th and 8th hours, a hand massage device will be used and manual hand massage will be applied in addition to the treatment according to the clinical analgesia protocol, and hand massage will be applied for 10 minutes for each hand. The control group will be treated only according to the clinical analgesia protocol. Before the massage and after the massage at 0, 4 and 8 hours; On the other hand, the 'Numerical Rating Scale', State Anxiety Scale' will be applied to the control group during the periods when other groups are massaged without hand massage, and the 'Gastrointestinal Functions Monitoring Form' will be filled.
All these evaluation stages will be done in the form of dividing 171 patients into 3 groups and evaluating them sequentially by numbering.
Application of manual hand massage: The researcher will receive certified training on hand massage. Hand massage application method will be determined after the training.
Application of machine-based hand massage: The pressure of the machine will be adjusted according to the manual massage application method. In manual massage and machine massage, machine adjustments will be made to keep the temperature and pressure difference as low as possible.
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- Manual hand massage after laparoscopic cholecystectomy surgery, Machine-based hand massage after laparoscopic cholecystectomy surgery
- Keywords
- Laparoscopic cholecystectomy, hand massage, postoperative anxiety, postoperative pain, gastrointestinal tract function, machine-based
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual hand massage after laparoscopic cholecystectomy surgeryOther
Manual hand massage is applied to a group of patients at 0, 4 and 8 hours after the patient returns from laparoscopic cholecystectomy surgery. It is applied to each hand for ten minutes.
Machine-based hand massage after laparoscopic cholecystectomy surgeryOther
Machine-based hand massage is applied to a group of patients at 0, 4 and 8 hours after the patient returns from laparoscopic cholecystectomy surgery. It is applied to each hand for ten minutes.
| Study group | Role | What they receive |
|---|---|---|
| Manuel hand massage group | Experimental | According to the hand massage training received, the patient coming out of the surgery is in diamond shape for ten minutes for each hand. Receives: Other: Manual hand massage after laparoscopic cholecystectomy surgery |
| machine-based hand massage | Experimental | The pressure setting of the machine is made according to the manual massage application method. In manual massage and machine massage, machine adjustments are made to keep the temperature and pressure difference as low as possible. A hand massage is done for ten minutes for each hand. Receives: Other: Machine-based hand massage after laparoscopic cholecystectomy surgery |
| Control group | No intervention | The control group will be treated only according to the clinical analgesia protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery
To see the effect of manual hand massage
Measured: It will be evaluated using the numerical rating scale (NRS) before the massage. A score of 0-10 is given on the NRS. A score of 0 on NRS means I have no pain. A score of 10 means I have unbearable pain.
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery
To see the effect of manual hand massage
Measured: It will be evaluated using the numerical rating scale (NRS) after the hand massage applied at the 0th hour. A score of 0-10 is given on the NRS. A score of 0 on NRS means no pain. 10 points means unbearable pain.
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery
To see the effect of manual hand massage
Measured: It will be evaluated using the numerical rating scale (NRS) after the hand massage applied at the 4th hour. A score of 0-10 is given on the NRS. A score of 0 on NRS means no pain. 10 points means unbearable pain.
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery
To see the effect of manual hand massage
Measured: It will be evaluated using the numerical rating scale (NRS) after the hand massage applied at the 8th hour. A score of 0-10 is given on the NRS. A score of 0 on NRS means no pain. 10 points means unbearable pain.
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery
To see the effect of machine-based hand massage
Measured: It will be evaluated using the numerical rating scale (NRS) before the massage. A score of 0-10 is given on the NRS. A score of 0 on NRS means I have no pain. A score of 10 means I have unbearable pain.
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery
To see the effect of machine-based hand massage
Measured: It will be evaluated using the numerical rating scale (NRS) after the hand massage applied at the 0th hour. A score of 0-10 is given on the NRS. A score of 0 on NRS means no pain. 10 points means unbearable pain.
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery
To see the effect of machine-based hand massage
Measured: It will be evaluated using the numerical rating scale (NRS) after the hand massage applied at the 4th hour. A score of 0-10 is given on the NRS. A score of 0 on NRS means no pain. 10 points means unbearable pain.
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery
To see the effect of machine-based hand massage
Measured: It will be evaluated using the numerical rating scale (NRS) after the hand massage applied at the 8th hour. A score of 0-10 is given on the NRS. A score of 0 on NRS means no pain. 10 points means unbearable pain.
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery
assessing patients who are not massaged (control group)
Measured: Immediately after surgery, it will be evaluated using the numerical rating scale. A score of 0-10 is given on the NRS. A score of 0 on NRS means I have no pain. A score of 10 means I have unbearable pain.
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery
assessing patients who are not massaged (control group)
Measured: After surgery at 0 hour it will be evaluated using a numerical rating scale. A score of 0-10 is given on the NRS. A score of 0 on NRS means I have no pain. A score of 10 means I have unbearable pain.
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery
assessing patients who are not massaged (control group)
Measured: After surgery at 4 hour it will be evaluated using a numerical rating scale. A score of 0-10 is given on the NRS. A score of 0 on NRS means I have no pain. A score of 10 means I
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery
assessing patients who are not massaged (control group)
Measured: After surgery at 8 hour it will be evaluated using a numerical rating scale. A score of 0-10 is given on the NRS. A score of 0 on NRS means I have no pain. A score of 10 means I
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
To see the effect of manual hand massage on state anxiety level
Measured: The State Anxiety Scale is used. The State Anxiety Scale will be used immediately after the surgery and before the massage to be performed at the 0th hour.
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
To see the effect of manual hand massage on state anxiety level
Measured: The State Anxiety Scale is used. The State Anxiety Scale will be used after the massage performed at the 0th hour after the surgery.
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
To see the effect of manual hand massage on state anxiety level
Measured: The State Anxiety Scale is used. The State Anxiety Scale will be used after the massage performed at the 4th hour after the surgery.
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
To see the effect of manual hand massage on state anxiety level
Measured: The State Anxiety Scale is used. The State Anxiety Scale will be used after the massage performed at the 8th hour after the surgery.
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
To see the effect of manual hand massage on trait anxiety level
Measured: The Trait Anxiety Scale is used. The Trait Anxiety Scale will be used once before the surgery.
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
To see the effect of machine-based hand massage on state anxiety level
Measured: The State Anxiety Scale is used. The State Anxiety Scale will be used immediately after the surgery and before the massage to be performed at the 0th hour.
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
To see the effect of machine-based hand massage on state anxiety level
Measured: The State Anxiety Scale is used. The State Anxiety Scale will be used after the massage performed at the 0th hour after the surgery.
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
To see the effect of machine-based hand massage on state anxiety level
Measured: The State Anxiety Scale is used. The State Anxiety Scale will be used after the massage performed at the 4th hour after the surgery.
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
To see the effect of machine-based hand massage on state anxiety level
Measured: The State Anxiety Scale is used. The State Anxiety Scale will be used after the massage performed at the 8th hour after the surgery.
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
To see the effect of machine-based hand massage on trait anxiety level
Measured: The Trait Anxiety Scale is used. The Trait Anxiety Scale will be used once before the surgery.
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
Evaluation of state anxiety level of patients who were not massaged (control group)
Measured: Immediately after surgery the State Anxiety Scale is used.
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
Evaluation of state anxiety level of patients who were not massaged (control group)
Measured: After surgery at 0th hour the State Anxiety Scale is used.
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
Evaluation of state anxiety level of patients who were not massaged (control group)
Measured: After surgery at 4th hour the State Anxiety Scale is used.
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
Evaluation of state anxiety level of patients who were not massaged (control group)
Measured: After surgery at 8th hour the State Anxiety Scale is used.
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
Evaluation of trait anxiety level of patients who were not massaged (control group)
Measured: The Trait Anxiety Scale is used. The Trait Anxiety Scale will be used once before the surgery.
The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
To see the effect of manual hand massage
Measured: The form of monitoring of gastrointestinal functions is used. Before the massage, it will be evaluated using a The form of monitoring of gastrointestinal functions.
The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
To see the effect of manual hand massage
Measured: The form of monitoring of gastrointestinal functions is used. After the hand massage applied at 0th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.
The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
To see the effect of manual hand massage
Measured: The form of monitoring of gastrointestinal functions is used. After the hand massage applied at 4th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.
The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
To see the effect of manual hand massage
Measured: The form of monitoring of gastrointestinal functions is used. After the hand massage applied at 8th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.
The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
To see the effect of machine-based hand massage
Measured: The form of monitoring of gastrointestinal functions is used. Before the massage, it will be evaluated using a The form of monitoring of gastrointestinal functions.
The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
To see the effect of machine-based hand massage
Measured: The form of monitoring of gastrointestinal functions is used. After the hand massage applied at 0th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.
The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
To see the effect of machine-based hand massage
Measured: The form of monitoring of gastrointestinal functions is used. After the hand massage applied at 4th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.
The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
To see the effect of machine-based hand massage
Measured: The form of monitoring of gastrointestinal functions is used. After the hand massage applied at 8th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.
The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
assessing patients who are not massaged (control group)
Measured: immediately after surgery, it will be evaluated using a The form of monitoring of gastrointestinal functions.
The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
assessing patients who are not massaged (control group)
Measured: After surgery at 0th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.
The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
assessing patients who are not massaged (control group)
Measured: After surgery at 4th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.
The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
assessing patients who are not massaged (control group)
Measured: After surgery at 8th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start1 Oct 2022
- Primary completionJun 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized controlled experimental study
- Masking
- None (open label)
- Enrolment
- 171 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Münevver Şengül
- Sponsor type
- University, hospital or other
- Collaborators
- Bartin State Hospital
- Responsible party
- Sponsor-investigator, Münevver Şengül, Bartın Unıversity
- Investigators
- Münevver Şengül, Principal investigator, mnvvrsngll58@gmail.comSevim Çelik, Study director, sevimakcel@yahoo.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636475
- Sponsor's protocol ID
- 2022-SBB-0329
- Status last verified
- Nov 2022
- First submitted
- 7 Nov 2022
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Machine-Based And Manually Applied Hand Massage On Pain, Anxiety And Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
- ClinicalTrials.gov ID
- NCT05636475
- Acronym / sponsor ID
- 2022-SBB-0329
- Conditions
- Laparoscopic Cholecystectomy
- Keywords
- Laparoscopic cholecystectomy, hand massage, postoperative anxiety, postoperative pain, gastrointestinal tract function, machine-based
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 171 participants (estimated)
- Lead sponsor
- Münevver ŞengülUniversity, hospital or other
- Collaborators
- Bartin State Hospital
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: As after almost every surgical procedure, changes in the patient's system functions, acute pain and an increase in anxiety level occur after laparoscopic cholecystectomy. Uncontrolled pain and anxiety slows down the healing process, increases the possibility of opioid use and the risk of undesirable side effects, and increases mortality, and prolongs hospital discharge.
Objective: The aim of the thesis study is to evaluate the effect of machine-based and manual hand massage applied in the postoperative period on pain, anxiety and gastrointestinal system functions in patients who have undergone laparoscopic cholecystectomy.
Method: In the study planned as a randomized controlled experimental study; There will be 3 groups, 57 patients in each group, including the experimental groups and the control group, who have undergone laparoscopic cholecystectomy and hospitalized in the General Surgery Clinic of Bartın State Hospital, where machine-based and manual hand massage will be applied. In addition to the analgesic treatment requested by the physician at the 0th, 4th and 8th hours after the surgery, the experimental groups will be given 10 minutes of hand massage to each hand, and only the requested treatment will be applied to the control group. After the applications, the changes in the pain and anxiety levels of the patients as well as the effects on the gastrointestinal system functions will be recorded. 'Data Collection Form', 'Numerical Rating Scale', 'State-Trait Anxiety Scale' and 'Gastrointestinal functions monitoring form' will be used to collect the data and the data will be analyzed in SPSS 22.0 program.
Detailed description
As with almost every surgical procedure, changes in the patient's system functions, acute pain and an increase in anxiety level occur after laparoscopic cholecystectomy. Uncontrolled pain and anxiety slows down the healing process, increases the possibility of opioid use and the risk of undesirable side effects, and increases mortality, and prolongs hospital discharge. Massage; increases patient comfort, relaxation and satisfaction and reduces stress. Receptors associated with nerve fibers that transmit pain to the brain are mostly found in the feet and hands. For this reason, the effect of hand massage was wanted to be examined.
The aim of the thesis study is to evaluate the effect of manual and machine-based application of hand massage on pain, anxiety and GIS functions after laparoscopic cholecystectomy. In the study planned as a randomized controlled experimental study; There will be 3 groups, 57 patients in each group, including the experimental groups and the control group, who have undergone laparoscopic cholecystectomy and hospitalized in the General Surgery Clinic of Bartın State Hospital, where machine-based and manual hand massage will be applied.
First, the researcher will receive certified training on hand massage. Necessary permissions will be obtained to carry out the research. Patients who have undergone laparoscopic cholecystectomy in the general surgery service of Bartın state hospital and meet the inclusion criteria will be divided into 3 groups, 2 experimental and 1 control group, by block randomization. Before starting the application, the purpose of the research will be explained by the researcher and the informed consent of the individuals will be obtained. Data will be collected between September 2022 and June 2023. The patient will fill in the 'Section 1 of the Data Collection Form' and the 'Trait Anxiety Scale' at least 1 hour before the surgery in the preoperative period. The second part will be filled at the most appropriate time after the surgery. When the patient comes to the service after the surgery, before the first hour is up, that is, at the 0th hour and at the 4th and 8th hours, a hand massage device will be used and manual hand massage will be applied in addition to the treatment according to the clinical analgesia protocol, and hand massage will be applied for 10 minutes for each hand. The control group will be treated only according to the clinical analgesia protocol. Before the massage and after the massage at 0, 4 and 8 hours; On the other hand, the 'Numerical Rating Scale', State Anxiety Scale' will be applied to the control group during the periods when other groups are massaged without hand massage, and the 'Gastrointestinal Functions Monitoring Form' will be filled.
All these evaluation stages will be done in the form of dividing 171 patients into 3 groups and evaluating them sequentially by numbering.
Application of manual hand massage: The researcher will receive certified training on hand massage. Hand massage application method will be determined after the training.
Application of machine-based hand massage: The pressure of the machine will be adjusted according to the manual massage application method. In manual massage and machine massage, machine adjustments will be made to keep the temperature and pressure difference as low as possible.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized controlled experimental study
| Arm | Type | Receives |
|---|---|---|
| Manuel hand massage group | Experimental | Other: Manual hand massage after laparoscopic cholecystectomy surgeryAccording to the hand massage training received, the patient coming out of the surgery is in diamond shape for ten minutes for each hand. |
| machine-based hand massage | Experimental | Other: Machine-based hand massage after laparoscopic cholecystectomy surgeryThe pressure setting of the machine is made according to the manual massage application method. In manual massage and machine massage, machine adjustments are made to keep the temperature and pressure difference as low as possible. A hand massage is done for ten minutes for each hand. |
| Control group | No intervention | –The control group will be treated only according to the clinical analgesia protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 years and over,
- Having undergone laparoscopic cholecystectomy,
- No complications after laparoscopic cholecystectomy,
- Receiving analgesia treatment according to the clinical protocol,
- Pain score >4 according to the Numerical Rating Scale,
Key exclusion criteria (9 listed)
- Having undergone open cholecystectomy,
- Complications after laparoscopic cholecystectomy,
- Pain score ≤4 according to the Numerical Rating Scale,
- Using analgesic drugs or methods other than clinical protocol,
- Having visual or auditory problems,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual hand massage after laparoscopic cholecystectomy surgeryManual hand massage is applied to a group of patients at 0, 4 and 8 hours after the patient returns from laparoscopic cholecystectomy surgery. It is applied to each hand for ten minutes. | Other | Manuel hand massage group |
| Machine-based hand massage after laparoscopic cholecystectomy surgeryMachine-based hand massage is applied to a group of patients at 0, 4 and 8 hours after the patient returns from laparoscopic cholecystectomy surgery. It is applied to each hand for ten minutes. | Other | machine-based hand massage |
Primary outcome
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery
Time frame: It will be evaluated using the numerical rating scale (NRS) before the massage. A score of 0-10 is given on the NRS. A score of 0 on NRS means I have no pain. A score of 10 means I have unbearable pain.
To see the effect of manual hand massage
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery
Time frame: It will be evaluated using the numerical rating scale (NRS) after the hand massage applied at the 0th hour. A score of 0-10 is given on the NRS. A score of 0 on NRS means no pain. 10 points means unbearable pain.
To see the effect of manual hand massage
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery
Time frame: It will be evaluated using the numerical rating scale (NRS) after the hand massage applied at the 4th hour. A score of 0-10 is given on the NRS. A score of 0 on NRS means no pain. 10 points means unbearable pain.
To see the effect of manual hand massage
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery
Time frame: It will be evaluated using the numerical rating scale (NRS) after the hand massage applied at the 8th hour. A score of 0-10 is given on the NRS. A score of 0 on NRS means no pain. 10 points means unbearable pain.
To see the effect of manual hand massage
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery
Time frame: It will be evaluated using the numerical rating scale (NRS) before the massage. A score of 0-10 is given on the NRS. A score of 0 on NRS means I have no pain. A score of 10 means I have unbearable pain.
To see the effect of machine-based hand massage
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery
Time frame: It will be evaluated using the numerical rating scale (NRS) after the hand massage applied at the 0th hour. A score of 0-10 is given on the NRS. A score of 0 on NRS means no pain. 10 points means unbearable pain.
To see the effect of machine-based hand massage
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery
Time frame: It will be evaluated using the numerical rating scale (NRS) after the hand massage applied at the 4th hour. A score of 0-10 is given on the NRS. A score of 0 on NRS means no pain. 10 points means unbearable pain.
To see the effect of machine-based hand massage
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery
Time frame: It will be evaluated using the numerical rating scale (NRS) after the hand massage applied at the 8th hour. A score of 0-10 is given on the NRS. A score of 0 on NRS means no pain. 10 points means unbearable pain.
To see the effect of machine-based hand massage
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery
Time frame: Immediately after surgery, it will be evaluated using the numerical rating scale. A score of 0-10 is given on the NRS. A score of 0 on NRS means I have no pain. A score of 10 means I have unbearable pain.
assessing patients who are not massaged (control group)
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery
Time frame: After surgery at 0 hour it will be evaluated using a numerical rating scale. A score of 0-10 is given on the NRS. A score of 0 on NRS means I have no pain. A score of 10 means I have unbearable pain.
assessing patients who are not massaged (control group)
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery
Time frame: After surgery at 4 hour it will be evaluated using a numerical rating scale. A score of 0-10 is given on the NRS. A score of 0 on NRS means I have no pain. A score of 10 means I
assessing patients who are not massaged (control group)
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery
Time frame: After surgery at 8 hour it will be evaluated using a numerical rating scale. A score of 0-10 is given on the NRS. A score of 0 on NRS means I have no pain. A score of 10 means I
assessing patients who are not massaged (control group)
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
Time frame: The State Anxiety Scale is used. The State Anxiety Scale will be used immediately after the surgery and before the massage to be performed at the 0th hour.
To see the effect of manual hand massage on state anxiety level
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
Time frame: The State Anxiety Scale is used. The State Anxiety Scale will be used after the massage performed at the 0th hour after the surgery.
To see the effect of manual hand massage on state anxiety level
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
Time frame: The State Anxiety Scale is used. The State Anxiety Scale will be used after the massage performed at the 4th hour after the surgery.
To see the effect of manual hand massage on state anxiety level
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
Time frame: The State Anxiety Scale is used. The State Anxiety Scale will be used after the massage performed at the 8th hour after the surgery.
To see the effect of manual hand massage on state anxiety level
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
Time frame: The Trait Anxiety Scale is used. The Trait Anxiety Scale will be used once before the surgery.
To see the effect of manual hand massage on trait anxiety level
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
Time frame: The State Anxiety Scale is used. The State Anxiety Scale will be used immediately after the surgery and before the massage to be performed at the 0th hour.
To see the effect of machine-based hand massage on state anxiety level
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
Time frame: The State Anxiety Scale is used. The State Anxiety Scale will be used after the massage performed at the 0th hour after the surgery.
To see the effect of machine-based hand massage on state anxiety level
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
Time frame: The State Anxiety Scale is used. The State Anxiety Scale will be used after the massage performed at the 4th hour after the surgery.
To see the effect of machine-based hand massage on state anxiety level
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
Time frame: The State Anxiety Scale is used. The State Anxiety Scale will be used after the massage performed at the 8th hour after the surgery.
To see the effect of machine-based hand massage on state anxiety level
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
Time frame: The Trait Anxiety Scale is used. The Trait Anxiety Scale will be used once before the surgery.
To see the effect of machine-based hand massage on trait anxiety level
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
Time frame: Immediately after surgery the State Anxiety Scale is used.
Evaluation of state anxiety level of patients who were not massaged (control group)
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
Time frame: After surgery at 0th hour the State Anxiety Scale is used.
Evaluation of state anxiety level of patients who were not massaged (control group)
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
Time frame: After surgery at 4th hour the State Anxiety Scale is used.
Evaluation of state anxiety level of patients who were not massaged (control group)
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
Time frame: After surgery at 8th hour the State Anxiety Scale is used.
Evaluation of state anxiety level of patients who were not massaged (control group)
The Effect of Machine-Based and Manually Applied Hand Massage on Anxiety After Laparoscopic Cholecystectomy Surgery
Time frame: The Trait Anxiety Scale is used. The Trait Anxiety Scale will be used once before the surgery.
Evaluation of trait anxiety level of patients who were not massaged (control group)
The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
Time frame: The form of monitoring of gastrointestinal functions is used. Before the massage, it will be evaluated using a The form of monitoring of gastrointestinal functions.
To see the effect of manual hand massage
The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
Time frame: The form of monitoring of gastrointestinal functions is used. After the hand massage applied at 0th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.
To see the effect of manual hand massage
The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
Time frame: The form of monitoring of gastrointestinal functions is used. After the hand massage applied at 4th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.
To see the effect of manual hand massage
The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
Time frame: The form of monitoring of gastrointestinal functions is used. After the hand massage applied at 8th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.
To see the effect of manual hand massage
The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
Time frame: The form of monitoring of gastrointestinal functions is used. Before the massage, it will be evaluated using a The form of monitoring of gastrointestinal functions.
To see the effect of machine-based hand massage
The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
Time frame: The form of monitoring of gastrointestinal functions is used. After the hand massage applied at 0th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.
To see the effect of machine-based hand massage
The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
Time frame: The form of monitoring of gastrointestinal functions is used. After the hand massage applied at 4th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.
To see the effect of machine-based hand massage
The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
Time frame: The form of monitoring of gastrointestinal functions is used. After the hand massage applied at 8th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.
To see the effect of machine-based hand massage
The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
Time frame: immediately after surgery, it will be evaluated using a The form of monitoring of gastrointestinal functions.
assessing patients who are not massaged (control group)
The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
Time frame: After surgery at 0th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.
assessing patients who are not massaged (control group)
The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
Time frame: After surgery at 4th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.
assessing patients who are not massaged (control group)
The Effect of Machine-Based and Manually Applied Hand Massage on Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery
Time frame: After surgery at 8th hour, it will be evaluated using a The form of monitoring of gastrointestinal functions.
assessing patients who are not massaged (control group)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Münevver Şengül principal investigator
mnvvrsngll58@gmail.com
Sevim Çelik study director
sevimakcel@yahoo.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual hand massage after laparoscopic cholecystectomy surgery and Machine-based hand massage after laparoscopic cholecystectomy surgery in people with Laparoscopic Cholecystectomy, run by Münevver Şengül at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Effect of Machine-Based and Manually Applied Hand Massage on Pain After Laparoscopic Cholecystectomy Surgery (time frame: It will be evaluated using the numerical rating scale (NRS) before the massage. A score of 0-10 is given on the NRS. A score of 0 on NRS means I have no pain. A score of 10 means I have unbearable pain.). The study lists 39 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022; AzTrials last refreshed its copy on 30 Oct 2026.