MassageSMALCNCT06480149
Shoulder Massage After Cholecystectomy
A study testing SMALC and no application in people with Massage and Sleep Quality, run by Maltepe University at 1 site in Turkey (Türkiye).
Trial summary
Purpose The aim of this study is to determine the effect of shoulder massage administered to patients after laparoscopic cholecystectomy on pain and sleep quality. Design The study was designed as a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Massage, Sleep Quality, Laparoscopic Cholecystectomy
- What is being tested?
- SMALC and no application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 31 Mar 2021
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Undergoing general anesthesia,
- Willing to participate in the research
Who cannot join
- Patients receiving epidural analgesia after surgery
- Patients who underwent a conversion from laparoscopic cholecystectomy to open cholecystectomy during the procedure
- Patients who did not develop shoulder pain after surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Shoulder Massage on Shoulder Pain and Sleep Quality in Patients After Laparoscopic Cholecystectomy
Purpose The aim of this study is to determine the effect of shoulder massage administered to patients after laparoscopic cholecystectomy on pain and sleep quality.
Design The study was designed as a randomized controlled trial. Methods This study was carried out with 60 patients who underwent surgery at the General Surgery Department of a university's Faculty of Medicine between January 2020 and March 2021. The study was completed with 60 patients (30 in the intervention group and 30 in the control group). The patients in the intervention group received shoulder massage twice at 6-hour intervals. The data for the study were collected using the "Individual Introduction Form", the "Visual Comparison Scale", and the "Richard Campbell Sleep Scale" .
Read the detailed description
The research population consisted of 132 patients who underwent laparoscopic cholecystectomy surgery at a private university hospital in Istanbul, Turkey, between January 2020 and March 2021. The sample size was calculated through a power analysis. According to the power analysis conducted, it was determined that a minimum of 52 individuals, with 26 in the experimental group and 26 in the control group, were needed to achieve 80% power at a significance level of 0.05. Considering data losses, and after excluding some patients who did not meet the inclusion criteria, a total of 60 patients were included in the sample, with 30 in the intervention group and 30 in the control group. The patients admitted to the hospital were assessed for eligibility by the nurse of the same doctor who would perform this surgery. Then, the patients were informed about the research by a nurse and asked to volunteer. Those who met the eligibility criteria were randomly assigned to either the experimental or control groups using a randomization blocking and coin-flip method, with the researcher being informed of the assignments. The study was concluded when the desired number of 30 patients in both experimental and control groups was reached using this method.
The pain levels of the patients in the intervention group were evaluated by the researcher using the Visual Analog Scale (VAS) when they regained consciousness approximately one hour after surgery. The patients were informed about the massage procedure and placed in the semi-fowler position, and olive oil was applied to the hands for lubrication. Classical shoulder massage was applied to both shoulders of the patient for 10-15 minutes each. 30 minutes after the massage, the patient's pain was reassessed using the VAS scale. Then, 6 hours later, the patient's pain was reassessed and shoulder massage was applied using the same techniques, followed by pain assessment 30 minutes later. Pharmacologic agents continued to be administered under the guidance of a physician throughout this process.
- Conditions
- Massage, Sleep Quality, Laparoscopic Cholecystectomy, Shoulder Pain
- Being tested
- SMALC, no application
- Keywords
- Massage, Laparoscopic Cholecystectomy, Sleep Quality, Shoulder Pain
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMALCOther
Classical shoulder massage was applied to both shoulders of the patient for 10-15 minutes each.
no applicationOther
In the control group, there was no massage application and only pain and sleep quality were evaluated.
| Study group | Role | What they receive |
|---|---|---|
| SMALC | Experimental | After laparoscopic surgery, the pain levels of the patients were evaluated and appropriate shoulder massage was applied to the patients 2 times at 6 st intervals and the pain levels of the patients were evaluated again. On the morning of the 1st postoperative day, the sleep quality of the patients was evaluated with the Richard Campbell Sleep Scale. Receives: Other: SMALC |
| control group | Other | After laparoscopic surgery, the pain levels of the patients were evaluated at the same hours as the intervention group and massage was not applied. On the morning of the 1st postoperative day, the sleep quality of the patients was evaluated with the Richard Campbell Sleep Scale. Receives: Other: no application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS)
In this scale developed to determine the severity of pain, patients are able to quantify their pain using numbers. It starts from the absence of pain (0) and goes up to the level of unbearable pain(10). According to the VAS, pain intensity is typically rated as 'no pain' with a score of 0 and 'the worst imaginable pain' with a score of 10 (on a 10 cm scale)
Measured: "through study completion, an average of 1 hour".
Richard-Campbell sleep scale
It is a 6-item scale used to assess the depth of nocturnal sleep, the time to fall asleep, the frequency of awakening, the duration of wakefulness upon awakening, the quality of sleep, and the level of ambient noise. Each item is evaluated on a chart ranging from 0 to 100 using the visual analog scale technique. Scores between "0-25" on the scale indicate very poor sleep quality, while scores between "76-100" indicate very good sleep quality.
Measured: "through study completion, an average of 12 hour".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start1 Jan 2020
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MassageStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study included 2 groups, experimental and control. The pain levels of the patients in the intervention group were evaluated one hour after surgery. Classical shoulder massage was applied to both shoulders of the patient for 10-15 minutes each. Patients in the control group were not massaged, only pain and sleep assessments were performed simultaneously with the intervention group.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maltepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şenay Öztürk, Maltepe University
- Investigators
- Senay Ozturk, Study director, Maltepe Univesity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480149
- Sponsor's protocol ID
- 2019/06-8
- Acronym
- SMALC
- Status last verified
- Jun 2024
- First submitted
- 14 Jun 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Duran MK, Ozturk S. The effect of shoulder massage on shoulder pain and sleep quality in patients after laparoscopic cholecystectomy: a randomized controlled trial. BMC Nurs. 2024 Sep 4;23(1):618. doi: 10.1186/s12912-024-02264-6.
PubMed 39232760
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Shoulder Massage on Shoulder Pain and Sleep Quality in Patients After Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06480149
- Acronym / sponsor ID
- SMALC / 2019/06-8
- Conditions
- Massage, Sleep Quality, Laparoscopic Cholecystectomy, Shoulder Pain
- Keywords
- Massage, Laparoscopic Cholecystectomy, Sleep Quality, Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Maltepe UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 28 Jun 2024 (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.
Purpose The aim of this study is to determine the effect of shoulder massage administered to patients after laparoscopic cholecystectomy on pain and sleep quality.
Design The study was designed as a randomized controlled trial. Methods This study was carried out with 60 patients who underwent surgery at the General Surgery Department of a university's Faculty of Medicine between January 2020 and March 2021. The study was completed with 60 patients (30 in the intervention group and 30 in the control group). The patients in the intervention group received shoulder massage twice at 6-hour intervals. The data for the study were collected using the "Individual Introduction Form", the "Visual Comparison Scale", and the "Richard Campbell Sleep Scale" .
Detailed description
The research population consisted of 132 patients who underwent laparoscopic cholecystectomy surgery at a private university hospital in Istanbul, Turkey, between January 2020 and March 2021. The sample size was calculated through a power analysis. According to the power analysis conducted, it was determined that a minimum of 52 individuals, with 26 in the experimental group and 26 in the control group, were needed to achieve 80% power at a significance level of 0.05. Considering data losses, and after excluding some patients who did not meet the inclusion criteria, a total of 60 patients were included in the sample, with 30 in the intervention group and 30 in the control group. The patients admitted to the hospital were assessed for eligibility by the nurse of the same doctor who would perform this surgery. Then, the patients were informed about the research by a nurse and asked to volunteer. Those who met the eligibility criteria were randomly assigned to either the experimental or control groups using a randomization blocking and coin-flip method, with the researcher being informed of the assignments. The study was concluded when the desired number of 30 patients in both experimental and control groups was reached using this method.
The pain levels of the patients in the intervention group were evaluated by the researcher using the Visual Analog Scale (VAS) when they regained consciousness approximately one hour after surgery. The patients were informed about the massage procedure and placed in the semi-fowler position, and olive oil was applied to the hands for lubrication. Classical shoulder massage was applied to both shoulders of the patient for 10-15 minutes each. 30 minutes after the massage, the patient's pain was reassessed using the VAS scale. Then, 6 hours later, the patient's pain was reassessed and shoulder massage was applied using the same techniques, followed by pain assessment 30 minutes later. Pharmacologic agents continued to be administered under the guidance of a physician throughout this process.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study included 2 groups, experimental and control. The pain levels of the patients in the intervention group were evaluated one hour after surgery. Classical shoulder massage was applied to both shoulders of the patient for 10-15 minutes each. Patients in the control group were not massaged, only pain and sleep assessments were performed simultaneously with the intervention group.
| Arm | Type | Receives |
|---|---|---|
| SMALC | Experimental | Other: SMALCAfter laparoscopic surgery, the pain levels of the patients were evaluated and appropriate shoulder massage was applied to the patients 2 times at 6 st intervals and the pain levels of the patients were evaluated again. On the morning of the 1st postoperative day, the sleep quality of the patients was evaluated with the Richard Campbell Sleep Scale. |
| control group | Other | Other: no applicationAfter laparoscopic surgery, the pain levels of the patients were evaluated at the same hours as the intervention group and massage was not applied. On the morning of the 1st postoperative day, the sleep quality of the patients was evaluated with the Richard Campbell Sleep Scale. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing general anesthesia,
- Willing to participate in the research
Key exclusion criteria (3 listed)
- Patients receiving epidural analgesia after surgery
- Patients who underwent a conversion from laparoscopic cholecystectomy to open cholecystectomy during the procedure
- Patients who did not develop shoulder pain after surgery
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 |
|---|---|---|
| SMALCClassical shoulder massage was applied to both shoulders of the patient for 10-15 minutes each. | Other | SMALC |
| no applicationIn the control group, there was no massage application and only pain and sleep quality were evaluated. | Other | control group |
Primary outcome
Visual analog scale (VAS)
Time frame: "through study completion, an average of 1 hour".
In this scale developed to determine the severity of pain, patients are able to quantify their pain using numbers. It starts from the absence of pain (0) and goes up to the level of unbearable pain(10). According to the VAS, pain intensity is typically rated as 'no pain' with a score of 0 and 'the worst imaginable pain' with a score of 10 (on a 10 cm scale)
Richard-Campbell sleep scale
Time frame: "through study completion, an average of 12 hour".
It is a 6-item scale used to assess the depth of nocturnal sleep, the time to fall asleep, the frequency of awakening, the duration of wakefulness upon awakening, the quality of sleep, and the level of ambient noise. Each item is evaluated on a chart ranging from 0 to 100 using the visual analog scale technique. Scores between "0-25" on the scale indicate very poor sleep quality, while scores between "76-100" indicate very good sleep quality.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Derived from this study: PubMed 39232760Duran MK, Ozturk S. The effect of shoulder massage on shoulder pain and sleep quality in patients after laparoscopic cholecystectomy: a randomized controlled trial. BMC Nurs. 2024 Sep 4;23(1):618. doi: 10.1186/s12912-024-02264-6.
- Individual participant dataSharing planned: Undecided
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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.
Senay Ozturk study director
Maltepe Univesity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMALC and no application in people with Massage and Sleep Quality, run by Maltepe 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 28 Jun 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual analog scale (VAS) (time frame: "through study completion, an average of 1 hour".). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06480149, which also lists 1 linked publication.
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 28 Jun 2024.