CholecystectomyNCT05149612
The Effect of Heat Therapy on Shoulder Pain and Physiologic Parameters After Laparoscopic Cholecystectomy
A study testing Heat Therapy in people with Cholecystectomy and Nursing Caries, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to determine the effect of hot application applied to patients undergoing laparoscopic cholecystectomy on shoulder pain and physiological parameters (blood pressure, pulse, respiratory rate, pain score, oxygen saturation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystectomy, Nursing Caries, Shoulder Pain
- What is being tested?
- Heat Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jul 2021to Jul 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- who agreed to participate in the research
- 18 years old and over
- BMI within normal limits
- VAS score of 5 or higher
Who cannot join
- who refused to participate in the research
- with a history of upper laparotomy
- Having endocrine, renal, hepatic or immunological disease
- ASA (American Society of Anesthesiologists) score above 3
- with chronic shoulder pain
- Regular use of analgesics
- using sedative drugs
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ordu Üniversitesi
Ordu, Altınordu, 52200
Hanife Durgun, PhD, 5549954010 ext. +90, hanife.balik@gmail.com
About this study
Official title: The Effect of Heat Therapy on Shoulder Pain and Physiologic Parameters After Laparoscopic Cholecystectomy: A Randomized Controlled Trail
This study was planned to determine the effect of hot application applied to patients undergoing laparoscopic cholecystectomy on shoulder pain and physiological parameters (blood pressure, pulse, respiratory rate, pain score, oxygen saturation.
The hypothesis of the study: To see the effect of hot application and its effect on physiological parameters after hot application in individuals who have undergone laparoscopic cholecystectomy.
Read more
The population of the study will consist of patients who were admitted to the OMU SUVAM General Surgery Service and underwent laparoscopic cholecystectomy.
The sample of the study will consist of individuals who have undergone 84 laparoscopic cholecystectomy operations, who agreed to participate in the study, and who met the criteria for inclusion in the study, between the specified dates.
The sample size of the study was determined in the G*Power 3.1.9.4 program by considering Cohen's standard effect sizes. Effect size was calculated based on 0.25, Type I error 0.05, Type II error 0.20 (80% power) and 38 patients were calculated for each group, but considering data loss, it was aimed to reach 10% more, with 42 patients for each group and 84 patients in total.
Which group the individuals in the sample group would be in was determined by randomization, and a randomization table was created over two groups.
In the study, data will be collected using the Patient Information Form, Visual Analogue Scale (VAS) and Physiological Parameter Form.
The patients in the intervention group will be treated with hot water bags twice, for 20 minutes in the morning and 20 minutes in the evening, to the shoulder area, starting four hours after the operation, until the patient is discharged.
When the individuals in the control group have pain, analgesic drug treatment will be applied at the request of the physician, and no other intervention will be applied.
Read the detailed description
In the management of shoulder pain experienced by individuals after laparoscopic cholecystectomy, pharmacological methods such as nonsteroidal anti-inflammatory drugs (NSAID), gabapentinoids, local analgesics, cyclooxygenase-2 (COX-2) inhibitors, transversus abdominis plane (TAP) block and opioids (Eftekhariyazdi et al. 2020; Gurusamy et al. 2014; Salazar-Perra et al. 2020) and peripheral techniques, cognitive behavioral techniques, and non-pharmacological methods other than these can be applied in order to increase the effectiveness of pharmacological methods or to increase the effectiveness of pharmacological methods (İbrahim and Ali 2020; Komann et al. et al. 2020; Pak et al. 2016; Tick et al. 2018; Şimsek Wild 2019).
One of the techniques commonly used to reduce or relieve pain among peripheral techniques is hot application. Hot application activates the gate control mechanism, stimulates tactile receptors, removes metabolic wastes, increases the release of endorphins, reduces muscle spasms as a result of the change in viscoelastic properties in tissues, reduces pressure, tension and hypoxia in nerve endings, raises the pain threshold, provides sedation and relaxes the individual. it reduces or relieves pain (Ibrahim and Ali 2020; Perry et al. 2017). In order to benefit from the therapeutic effect of hot application, the application time should not exceed 30 minutes. If the application period lasts more than 35-40 minutes, congestion occurs in the tissue, and in hot applications lasting more than one hour, vasoconstriction may occur instead of vasodilation, and the opposite of the desired effect may occur. In hot application, the temperature is as important as the time. Although there is no evidence-based guideline for hot applications, the temperature should be 40-45ºC.
It is recommended that hot application at these temperatures has a therapeutic effect by giving heat to the skin (Ibrahim and Ali 2020; Türkmen 2017). In addition, it has an important place in nursing practices as one of the preferred nursing interventions in the non-pharmacological treatment of pain due to its ease of use, high level of patient satisfaction and rare side effects (Mohamed 2016; Perry et al. 2017).
Although there are studies in the literature in which different non-pharmacological nursing interventions have been applied to manage the shoulder pain experienced by individuals after cholecystectomy, no study has been found in which warm application has been made. Therefore, this study was planned to examine the effect of hot application applied to patients who underwent laparoscopic cholecystectomy on shoulder pain and physiological parameters.
This study was planned to determine the effect of hot application applied to patients undergoing laparoscopic cholecystectomy on shoulder pain and physiological parameters.
The hypotheses of the study:
H01: Warm application applied after laparoscopic cholecystectomy is not effective in reducing shoulder pain experienced by individuals.
H11: Warm application applied after laparoscopic cholecystectomy reduces the shoulder pain experienced by individuals.
H02: Warm application applied after laparoscopic cholecystectomy is not effective in maintaining the physiological parameters of individuals within normal limits.
H12: Warm application applied after laparoscopic cholecystectomy ensures that the physiological parameters of the patients are maintained within normal limits.
- Conditions
- Cholecystectomy, Nursing Caries, Shoulder Pain
- Being tested
- Heat Therapy
- Keywords
- hot application, postoperative pain, nursing care, laparoscopic cholecystectomy
- Medical subject headings
- Shoulder Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heat TherapyOther
Patients in the intervention group will be treated with hot water bags twice, 20 minutes in the morning and 20 minutes in the evening, starting four hours after the operation until discharge. In accordance with the literature, the water bag filled with 55 ± 2°C hot water will be wrapped with 2 towels. The water bag will be applied to the shoulder area while the patient is in the fawler or semi-fawler position. After 20 minutes, the hot application will be terminated. Pain and physiological parameters of the patients will be evaluated at the 0th minute, 30th minute, 4th hour, 12th hour, 24th hour and 48th hour postoperatively. At the same time, when individuals have pain, analgesics will be administered at the request of the physician.
| Study group | Role | What they receive |
|---|---|---|
| Heat Therapy Group | Experimental | The patients in the intervention group will be treated with hot water bags twice, for 20 minutes in the morning and 20 minutes in the evening, to the shoulder area, starting four hours after the operation, until the patient is discharged. Receives: Other: Heat Therapy |
| Control group | No intervention | When the individuals in the control group have pain, analgesic drug treatment will be applied at the request of the physician, and no other intervention will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain
Measured: At the 0th minute right after the patients come from the operation
Pain Score
The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain
Measured: At the 30th minute after the patients come from the operation
Pain Score
The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain
Measured: At the 4th hour after the patients come from the operation,
Pain Score
The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain
Measured: At the 12th hour after the patients come from the operation
Pain Score
The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain
Measured: At the 24th hour after the patients come from the operation
pain Score
The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain
Measured: At the 48th hour after the patients come from the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start6 Jul 2021
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Parallel groups
- Model description
- The individuals in the sample group will be divided into two groups as the hot application group and the control group. Individuals in the control group will not be treated with heat.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanife DURGUN, Ordu University
- Investigators
- Hanife Durgun, PhD, Principal investigator, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149612
- Sponsor's protocol ID
- cholecystectomy
- Status last verified
- Nov 2021
- First submitted
- 26 Nov 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Heat Therapy on Shoulder Pain and Physiologic Parameters After Laparoscopic Cholecystectomy: A Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT05149612
- Acronym / sponsor ID
- cholecystectomy
- Conditions
- Cholecystectomy, Nursing Caries, Shoulder Pain
- Keywords
- hot application, postoperative pain, nursing care, laparoscopic cholecystectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 8 Dec 2021 (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.
This study was planned to determine the effect of hot application applied to patients undergoing laparoscopic cholecystectomy on shoulder pain and physiological parameters (blood pressure, pulse, respiratory rate, pain score, oxygen saturation.
The hypothesis of the study: To see the effect of hot application and its effect on physiological parameters after hot application in individuals who have undergone laparoscopic cholecystectomy.
The population of the study will consist of patients who were admitted to the OMU SUVAM General Surgery Service and underwent laparoscopic cholecystectomy.
The sample of the study will consist of individuals who have undergone 84 laparoscopic cholecystectomy operations, who agreed to participate in the study, and who met the criteria for inclusion in the study, between the specified dates.
The sample size of the study was determined in the G*Power 3.1.9.4 program by considering Cohen's standard effect sizes. Effect size was calculated based on 0.25, Type I error 0.05, Type II error 0.20 (80% power) and 38 patients were calculated for each group, but considering data loss, it was aimed to reach 10% more, with 42 patients for each group and 84 patients in total.
Which group the individuals in the sample group would be in was determined by randomization, and a randomization table was created over two groups.
In the study, data will be collected using the Patient Information Form, Visual Analogue Scale (VAS) and Physiological Parameter Form.
The patients in the intervention group will be treated with hot water bags twice, for 20 minutes in the morning and 20 minutes in the evening, to the shoulder area, starting four hours after the operation, until the patient is discharged.
When the individuals in the control group have pain, analgesic drug treatment will be applied at the request of the physician, and no other intervention will be applied.
Detailed description
In the management of shoulder pain experienced by individuals after laparoscopic cholecystectomy, pharmacological methods such as nonsteroidal anti-inflammatory drugs (NSAID), gabapentinoids, local analgesics, cyclooxygenase-2 (COX-2) inhibitors, transversus abdominis plane (TAP) block and opioids (Eftekhariyazdi et al. 2020; Gurusamy et al. 2014; Salazar-Perra et al. 2020) and peripheral techniques, cognitive behavioral techniques, and non-pharmacological methods other than these can be applied in order to increase the effectiveness of pharmacological methods or to increase the effectiveness of pharmacological methods (İbrahim and Ali 2020; Komann et al. et al. 2020; Pak et al. 2016; Tick et al. 2018; Şimsek Wild 2019).
One of the techniques commonly used to reduce or relieve pain among peripheral techniques is hot application. Hot application activates the gate control mechanism, stimulates tactile receptors, removes metabolic wastes, increases the release of endorphins, reduces muscle spasms as a result of the change in viscoelastic properties in tissues, reduces pressure, tension and hypoxia in nerve endings, raises the pain threshold, provides sedation and relaxes the individual. it reduces or relieves pain (Ibrahim and Ali 2020; Perry et al. 2017). In order to benefit from the therapeutic effect of hot application, the application time should not exceed 30 minutes. If the application period lasts more than 35-40 minutes, congestion occurs in the tissue, and in hot applications lasting more than one hour, vasoconstriction may occur instead of vasodilation, and the opposite of the desired effect may occur. In hot application, the temperature is as important as the time. Although there is no evidence-based guideline for hot applications, the temperature should be 40-45ºC.
It is recommended that hot application at these temperatures has a therapeutic effect by giving heat to the skin (Ibrahim and Ali 2020; Türkmen 2017). In addition, it has an important place in nursing practices as one of the preferred nursing interventions in the non-pharmacological treatment of pain due to its ease of use, high level of patient satisfaction and rare side effects (Mohamed 2016; Perry et al. 2017).
Although there are studies in the literature in which different non-pharmacological nursing interventions have been applied to manage the shoulder pain experienced by individuals after cholecystectomy, no study has been found in which warm application has been made. Therefore, this study was planned to examine the effect of hot application applied to patients who underwent laparoscopic cholecystectomy on shoulder pain and physiological parameters.
This study was planned to determine the effect of hot application applied to patients undergoing laparoscopic cholecystectomy on shoulder pain and physiological parameters.
The hypotheses of the study:
H01: Warm application applied after laparoscopic cholecystectomy is not effective in reducing shoulder pain experienced by individuals.
H11: Warm application applied after laparoscopic cholecystectomy reduces the shoulder pain experienced by individuals.
H02: Warm application applied after laparoscopic cholecystectomy is not effective in maintaining the physiological parameters of individuals within normal limits.
H12: Warm application applied after laparoscopic cholecystectomy ensures that the physiological parameters of the patients are maintained within normal limits.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The individuals in the sample group will be divided into two groups as the hot application group and the control group. Individuals in the control group will not be treated with heat.
| Arm | Type | Receives |
|---|---|---|
| Heat Therapy Group | Experimental | Other: Heat TherapyThe patients in the intervention group will be treated with hot water bags twice, for 20 minutes in the morning and 20 minutes in the evening, to the shoulder area, starting four hours after the operation, until the patient is discharged. |
| Control group | No intervention | –When the individuals in the control group have pain, analgesic drug treatment will be applied at the request of the physician, and no other intervention will be applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- who agreed to participate in the research
- 18 years old and over
- BMI within normal limits
- VAS score of 5 or higher
Key exclusion criteria (7 listed)
- who refused to participate in the research
- with a history of upper laparotomy
- Having endocrine, renal, hepatic or immunological disease
- ASA (American Society of Anesthesiologists) score above 3
- with chronic shoulder pain
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 |
|---|---|---|
| Heat TherapyPatients in the intervention group will be treated with hot water bags twice, 20 minutes in the morning and 20 minutes in the evening, starting four hours after the operation until discharge. In accordance with the literature, the water bag filled with 55 ± 2°C hot water will be wrapped with 2 towels. The water bag will be applied to the shoulder area while the patient is in the fawler or semi-fawler position. After 20 minutes, the hot application will be terminated. Pain and physiological parameters of the patients will be evaluated at the 0th minute, 30th minute, 4th hour, 12th hour, 24th hour and 48th hour postoperatively. At the same time, when individuals have pain, analgesics will be administered at the request of the physician. | Other | Heat Therapy Group |
Primary outcome
Pain Score
Time frame: At the 0th minute right after the patients come from the operation
The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain
Pain Score
Time frame: At the 30th minute after the patients come from the operation
The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain
Pain Score
Time frame: At the 4th hour after the patients come from the operation,
The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain
Pain Score
Time frame: At the 12th hour after the patients come from the operation
The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain
Pain Score
Time frame: At the 24th hour after the patients come from the operation
The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain
pain Score
Time frame: At the 48th hour after the patients come from the operation
The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
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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.
Hanife Durgun, PhD principal investigator
Ordu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heat Therapy in people with Cholecystectomy and Nursing Caries, run by Ordu University 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 4 inclusion and 7 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 8 Dec 2021. 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?
Contact Feyza Bayraktar, bachelor's (5530941996 ext. +90, fyzbyrktr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (time frame: At the 0th minute right after the patients come from the operation). The study lists 6 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 8 Dec 2021.