Laparoscopic CholecystectomyNCT07913724
Heat Application and Shoulder Pillow for Post-Laparoscopic Shoulder Pain
A study testing heat application and shoulder support pillow in people with Laparoscopic Cholecystectomy and Shoulder Pain, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to learn whether heat application combined with a shoulder support pillow reduces shoulder pain in adults (18 years and older) who undergo elective laparoscopic cholecystectomy and develop shoulder pain within the first 2 hours after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Cholecystectomy, Shoulder Pain
- What is being tested?
- heat application and shoulder support pillow
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Being over 18 years of age
- Undergoing elective laparoscopic cholecystectomy
- Having an ASA score of I or II
- Being a patient with shoulder pain within the first 2 hours after surgery
- Agreeing to participate in the research
Who cannot join
- Patients with chronic shoulder pain in the preoperative period
- Patients converted to open surgery
- Patients with any wound or lesion in the shoulder region
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Sağlık Bilimleri Üniversitesi
Ankara, Kecioren, 06020
About this study
Official title: The Effectiveness of Heat Application and a Shoulder Support Pillow in Reducing Shoulder Pain After Laparoscopic Cholecystectomy: A Randomized Controlled Trial
The goal of this clinical trial is to learn whether heat application combined with a shoulder support pillow reduces shoulder pain in adults (18 years and older) who undergo elective laparoscopic cholecystectomy and develop shoulder pain within the first 2 hours after surgery. The main questions it aims to answer are:
Does heat application with a shoulder support pillow reduce postoperative shoulder pain scores during the first 24 hours after surgery? Does it reduce incision pain and the amount of analgesics used within 24 hours after surgery?
Read more
Researchers will compare patients receiving heat application and a shoulder support pillow with patients receiving routine postoperative care only, to see if the intervention lowers shoulder pain, incision pain and analgesic consumption.
Participants will be randomly assigned to the intervention group or the control group.
Participants in the intervention group will:
Receive heat application with a towel-wrapped thermal gel pack (maximum 40°C) to the right trapezius and upper scapular region for 20 minutes at postoperative hours 2, 4, 6 and 8 Use a fiber-filled shoulder support pillow under the right shoulder and arm for 24 hours after surgery, except during mobilization
Participants in the control group will:
Receive no study intervention and will receive routine postoperative care only
All participants in both groups will:
Rate their shoulder pain and incision pain on a 0-10 Numerical Rating Scale at postoperative hours 1, 3, 5, 7, 9, 11, 20 and 24 Have their analgesic use during the first 24 hours after surgery recorded
- Conditions
- Laparoscopic Cholecystectomy, Shoulder Pain
- Being tested
- heat application and shoulder support pillow
- Keywords
- Laparoscopic Cholecystectomy, shoulder pain, heat application, Shoulder Support Pillow
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heat application and shoulder support pillowOther
Heat application will be applied to the trapezius muscle and the upper scapular region for 20 minutes at postoperative hours 2, 4, 6 and 8. For heat application, a 26x35 cm self-fabric-covered thermal gel pack will be heated in a microwave oven at medium heat for 15 seconds, wrapped in a towel at a maximum temperature of 40 degrees, and applied to the patient. The patient's skin will be checked throughout the application. The shoulder support pillow will be used for 24 hours from the moment the patient is transferred to the bed after surgery, except when the patient is mobilized
| Study group | Role | What they receive |
|---|---|---|
| Heat application and shoulder support pillow group | Experimental | Heat application will be applied to the trapezius muscle and the upper scapular region for 20 minutes at postoperative hours 2, 4, 6 and 8. For heat application, a 26x35 cm self-fabric-covered thermal gel pack will be heated in a microwave oven at medium heat for 15 seconds, wrapped in a towel at a maximum temperature of 40 degrees, and applied to the patient. The patient's skin will be checked throughout the application. The shoulder support pillow will be used for 24 hours from the moment the patient is transferred to the bed after surgery, except when the patient is mobilized. Receives: Other: heat application and shoulder support pillow |
| Control group | No intervention | Receive no study intervention and will receive routine postoperative care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder and incision pain at 1, 3, 5, 7, 9, 11, 20, and 24 hours postoperatively.
This will be scored using the 0-10 Numerical Rating Scale.
Measured: Shoulder and incision pain during the first 24 postoperative hours.
Secondary outcomes (1)
the amount of analgesic used during the first 24 hours postoperatively
The amount of analgesics used by the patients during 24 hours will be recorded
Measured: The amount of analgesics during the first 24 postoperative hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Oct 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bediye Öztaş, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913724
- Sponsor's protocol ID
- 46418926/Decision no:2026-224
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Publications
Tsai HW, Chen YJ, Ho CM, Hseu SS, Chao KC, Tsai SK, Wang PH. Maneuvers to decrease laparoscopy-induced shoulder and upper abdominal pain: a randomized controlled study. Arch Surg. 2011 Dec;146(12):1360-6. doi: 10.1001/archsurg.2011.597.
PubMed 22184293Donatsky AM, Bjerrum F, Gogenur I. Surgical techniques to minimize shoulder pain after laparoscopic cholecystectomy. A systematic review. Surg Endosc. 2013 Jul;27(7):2275-82. doi: 10.1007/s00464-012-2759-5. Epub 2013 Jan 24.
PubMed 23340814Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.
PubMed 26827847Bin C, Cimin S, Li N, Wang L, Chen D. Thermotherapy for shoulder pain: A protocol for systematic review. Medicine (Baltimore). 2022 Jan 21;101(3):e28446. doi: 10.1097/MD.0000000000028446.
PubMed 35060498
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Heat Application and a Shoulder Support Pillow in Reducing Shoulder Pain After Laparoscopic Cholecystectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07913724
- Acronym / sponsor ID
- 46418926/Decision no:2026-224
- Conditions
- Laparoscopic Cholecystectomy, Shoulder Pain
- Keywords
- Laparoscopic Cholecystectomy, shoulder pain, heat application, Shoulder Support Pillow
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Nov 2026 (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.
The goal of this clinical trial is to learn whether heat application combined with a shoulder support pillow reduces shoulder pain in adults (18 years and older) who undergo elective laparoscopic cholecystectomy and develop shoulder pain within the first 2 hours after surgery. The main questions it aims to answer are:
Does heat application with a shoulder support pillow reduce postoperative shoulder pain scores during the first 24 hours after surgery? Does it reduce incision pain and the amount of analgesics used within 24 hours after surgery?
Researchers will compare patients receiving heat application and a shoulder support pillow with patients receiving routine postoperative care only, to see if the intervention lowers shoulder pain, incision pain and analgesic consumption.
Participants will be randomly assigned to the intervention group or the control group.
Participants in the intervention group will:
Receive heat application with a towel-wrapped thermal gel pack (maximum 40°C) to the right trapezius and upper scapular region for 20 minutes at postoperative hours 2, 4, 6 and 8 Use a fiber-filled shoulder support pillow under the right shoulder and arm for 24 hours after surgery, except during mobilization
Participants in the control group will:
Receive no study intervention and will receive routine postoperative care only
All participants in both groups will:
Rate their shoulder pain and incision pain on a 0-10 Numerical Rating Scale at postoperative hours 1, 3, 5, 7, 9, 11, 20 and 24 Have their analgesic use during the first 24 hours after surgery recorded
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heat application and shoulder support pillow group | Experimental | Other: heat application and shoulder support pillowHeat application will be applied to the trapezius muscle and the upper scapular region for 20 minutes at postoperative hours 2, 4, 6 and 8. For heat application, a 26x35 cm self-fabric-covered thermal gel pack will be heated in a microwave oven at medium heat for 15 seconds, wrapped in a towel at a maximum temperature of 40 degrees, and applied to the patient. The patient's skin will be checked throughout the application. The shoulder support pillow will be used for 24 hours from the moment the patient is transferred to the bed after surgery, except when the patient is mobilized. |
| Control group | No intervention | –Receive no study intervention and will receive routine postoperative care only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being over 18 years of age
- Undergoing elective laparoscopic cholecystectomy
- Having an ASA score of I or II
- Being a patient with shoulder pain within the first 2 hours after surgery
- Agreeing to participate in the research
Key exclusion criteria (3 listed)
- Patients with chronic shoulder pain in the preoperative period
- Patients converted to open surgery
- Patients with any wound or lesion in the shoulder region
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 application and shoulder support pillowHeat application will be applied to the trapezius muscle and the upper scapular region for 20 minutes at postoperative hours 2, 4, 6 and 8. For heat application, a 26x35 cm self-fabric-covered thermal gel pack will be heated in a microwave oven at medium heat for 15 seconds, wrapped in a towel at a maximum temperature of 40 degrees, and applied to the patient. The patient's skin will be checked throughout the application. The shoulder support pillow will be used for 24 hours from the moment the patient is transferred to the bed after surgery, except when the patient is mobilized | Other | Heat application and shoulder support pillow group |
Primary outcome
Shoulder and incision pain at 1, 3, 5, 7, 9, 11, 20, and 24 hours postoperatively.
Time frame: Shoulder and incision pain during the first 24 postoperative hours.
This will be scored using the 0-10 Numerical Rating Scale.
1 secondary outcome
the amount of analgesic used during the first 24 hours postoperatively
Time frame: The amount of analgesics during the first 24 postoperative hours.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 22184293Tsai HW, Chen YJ, Ho CM, Hseu SS, Chao KC, Tsai SK, Wang PH. Maneuvers to decrease laparoscopy-induced shoulder and upper abdominal pain: a randomized controlled study. Arch Surg. 2011 Dec;146(12):1360-6. doi: 10.1001/archsurg.2011.597.
- Background: PubMed 23340814Donatsky AM, Bjerrum F, Gogenur I. Surgical techniques to minimize shoulder pain after laparoscopic cholecystectomy. A systematic review. Surg Endosc. 2013 Jul;27(7):2275-82. doi: 10.1007/s00464-012-2759-5. Epub 2013 Jan 24.
- Background: PubMed 26827847Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.
- Results publication: PubMed 35060498Bin C, Cimin S, Li N, Wang L, Chen D. Thermotherapy for shoulder pain: A protocol for systematic review. Medicine (Baltimore). 2022 Jan 21;101(3):e28446. doi: 10.1097/MD.0000000000028446.
- Individual participant dataSharing planned: Undecided. 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.
The record lists no contact. Use the official record to reach the sponsor.
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 application and shoulder support pillow in people with Laparoscopic Cholecystectomy and Shoulder Pain, run by Saglik Bilimleri Universitesi 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 5 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: enrolling by invitation, as of the sponsor's last update on 3 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Shoulder and incision pain at 1, 3, 5, 7, 9, 11, 20, and 24 hours postoperatively. (time frame: Shoulder and incision pain during the first 24 postoperative hours.). 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 NCT07913724, which also lists 4 linked publications.
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 3 Nov 2026.