Postoperative Pain ManagementnursingNCT07417319
Nursing Heat Therapy After Cholecystectomy
A study testing Local Heat Application in people with Postoperative Pain Management, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study aims to evaluate the effect of local heat application to the feet on postoperative pain and abdominal distension in patients undergoing open or laparoscopic cholecystectomy. Eligible participants will be randomly assigned to either a local heat application group or a control group. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Postoperative Pain Management
- What is being tested?
- Local Heat Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Feb 2025to 1 Feb 2026
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Had undergone laparoscopic cholecystectomy,
- American Society of Anesthesiologists (ASA) physical status classification of I-II.
Who cannot join
- Had any neurological or psychiatric disorders,
- Conditions that could interfere with heat perception,
- Contraindications to foot heat application,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aydın Adnan Menderes University Faculty of Nursing
Aydin, Efeler, 09100
About this study
Official title: Effects Of Nursing-Led Local Heat Application To The Feet On Postoperative Pain And Abdominal Distension After Cholecystectomy: A Randomised Controlled Trial
This randomized controlled study aims to evaluate the effect of local heat application to the feet on postoperative pain and abdominal distension in patients undergoing open or laparoscopic cholecystectomy. Eligible participants will be randomly assigned to either a local heat application group or a control group. In the intervention group, heat will be applied to the feet using a hot-water bottle for 15 minutes at hourly intervals during the first four postoperative hours. Pain and abdominal distension will be assessed using validated scales, and gastrointestinal recovery indicators such as time to first flatus and defecation will be recorded. The study is designed to determine whether this simple, nurse-led, non-pharmacological intervention may improve postoperative comfort and recovery.
Read the detailed description
Gallstone disease is a common health problem worldwide and represents a substantial clinical and economic burden. Cholecystectomy is among the most frequently performed abdominal surgical procedures, and postoperative symptoms such as pain and abdominal distension may delay mobilization, impair comfort, and prolong recovery. Postoperative ileus, characterized by temporary impairment of gastrointestinal motility, abdominal distension, and delayed passage of flatus or stool, is frequently observed following abdominal surgery.
Pharmacological analgesia, particularly opioid-based regimens, remains the standard approach for postoperative pain management; however, these medications may contribute to gastrointestinal dysmotility and delayed recovery. Therefore, non-pharmacological and nurse-led interventions are increasingly considered as complementary strategies to enhance patient outcomes and comfort. Approaches such as early mobilization, education, and sensory or physical modalities have been suggested to support recovery.
Local heat therapy is a simple, low-cost nursing intervention that may promote pain relief and physiological recovery through mechanisms including increased local circulation, muscle relaxation, and modulation of nociceptive pathways. Distal thermal applications, such as foot-based heat therapy, may influence autonomic regulation and gastrointestinal activity; however, evidence in patients undergoing cholecystectomy remains limited.
This study is designed as a single-blind randomized controlled trial to evaluate the effects of foot-based local heat application on postoperative pain, abdominal distension, and gastrointestinal recovery outcomes. Findings are expected to contribute to the evidence base for safe and feasible nursing interventions in postoperative care.
- Conditions
- Postoperative Pain Management
- Being tested
- Local Heat Application
- Keywords
- Nursing interventions; Non-pharmacological pain management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local Heat ApplicationOther
Local heat was applied to both feet using warm hot packs at approximately 40-42°C. The application lasted 15-20 minutes and was administered twice daily for the first 48 hours postoperatively in addition to standard nursing care and early mobilization.
| Study group | Role | What they receive |
|---|---|---|
| Local Heat Therapy Group | Experimental | Participants received local heat application to both feet using warm compresses/hot packs at 40-42°C for 15-20 minutes twice daily during the first 48 hours postoperatively in addition to standard nursing care and early mobilization. Postoperative pain intensity and abdominal distension were assessed at predetermined time points using validated measurement scales. Receives: Other: Local Heat Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal Distension
Abdominal distension measured using the Abdominal Distension Scale (0-3) at 6, 12, 24, and 48 hours postoperatively.
Measured: At 6, 12, 24, and 48 hours postoperatively
Acute Postoperative Pain
Postoperative pain intensity measured by the Numeric Rating Scale (NRS, 0-10) at 6, 12, 24, and 48 hours postoperatively.
Measured: 6, 12, 24, and 48 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start3 Feb 2025
- Primary completion1 Oct 2025
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain ManagementStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- single-blind randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel Tuğrul, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417319
- Sponsor's protocol ID
- ADU Nursing Faculty
- Acronym
- nursing
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to patient confidentiality and institutional ethical restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Nursing-Led Local Heat Application To The Feet On Postoperative Pain And Abdominal Distension After Cholecystectomy: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07417319
- Acronym / sponsor ID
- nursing / ADU Nursing Faculty
- Conditions
- Postoperative Pain Management
- Keywords
- Nursing interventions; Non-pharmacological pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 18 Feb 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.
This randomized controlled study aims to evaluate the effect of local heat application to the feet on postoperative pain and abdominal distension in patients undergoing open or laparoscopic cholecystectomy. Eligible participants will be randomly assigned to either a local heat application group or a control group. In the intervention group, heat will be applied to the feet using a hot-water bottle for 15 minutes at hourly intervals during the first four postoperative hours. Pain and abdominal distension will be assessed using validated scales, and gastrointestinal recovery indicators such as time to first flatus and defecation will be recorded. The study is designed to determine whether this simple, nurse-led, non-pharmacological intervention may improve postoperative comfort and recovery.
Detailed description
Gallstone disease is a common health problem worldwide and represents a substantial clinical and economic burden. Cholecystectomy is among the most frequently performed abdominal surgical procedures, and postoperative symptoms such as pain and abdominal distension may delay mobilization, impair comfort, and prolong recovery. Postoperative ileus, characterized by temporary impairment of gastrointestinal motility, abdominal distension, and delayed passage of flatus or stool, is frequently observed following abdominal surgery.
Pharmacological analgesia, particularly opioid-based regimens, remains the standard approach for postoperative pain management; however, these medications may contribute to gastrointestinal dysmotility and delayed recovery. Therefore, non-pharmacological and nurse-led interventions are increasingly considered as complementary strategies to enhance patient outcomes and comfort. Approaches such as early mobilization, education, and sensory or physical modalities have been suggested to support recovery.
Local heat therapy is a simple, low-cost nursing intervention that may promote pain relief and physiological recovery through mechanisms including increased local circulation, muscle relaxation, and modulation of nociceptive pathways. Distal thermal applications, such as foot-based heat therapy, may influence autonomic regulation and gastrointestinal activity; however, evidence in patients undergoing cholecystectomy remains limited.
This study is designed as a single-blind randomized controlled trial to evaluate the effects of foot-based local heat application on postoperative pain, abdominal distension, and gastrointestinal recovery outcomes. Findings are expected to contribute to the evidence base for safe and feasible nursing interventions in postoperative care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-blind randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Local Heat Therapy Group | Experimental | Other: Local Heat ApplicationParticipants received local heat application to both feet using warm compresses/hot packs at 40-42°C for 15-20 minutes twice daily during the first 48 hours postoperatively in addition to standard nursing care and early mobilization. Postoperative pain intensity and abdominal distension were assessed at predetermined time points using validated measurement scales. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Had undergone laparoscopic cholecystectomy,
- American Society of Anesthesiologists (ASA) physical status classification of I-II.
Key exclusion criteria (3 listed)
- Had any neurological or psychiatric disorders,
- Conditions that could interfere with heat perception,
- Contraindications to foot heat application,
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 |
|---|---|---|
| Local Heat ApplicationLocal heat was applied to both feet using warm hot packs at approximately 40-42°C. The application lasted 15-20 minutes and was administered twice daily for the first 48 hours postoperatively in addition to standard nursing care and early mobilization. | Other | Local Heat Therapy Group |
Primary outcome
Abdominal Distension
Time frame: At 6, 12, 24, and 48 hours postoperatively
Abdominal distension measured using the Abdominal Distension Scale (0-3) at 6, 12, 24, and 48 hours postoperatively.
Acute Postoperative Pain
Time frame: 6, 12, 24, and 48 hours postoperatively.
Postoperative pain intensity measured by the Numeric Rating Scale (NRS, 0-10) at 6, 12, 24, and 48 hours postoperatively.
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 18 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to patient confidentiality and institutional ethical restrictions.
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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.
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 Local Heat Application in people with Postoperative Pain Management, run by Aydin Adnan Menderes 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 18 Feb 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?
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?
Abdominal Distension (time frame: At 6, 12, 24, and 48 hours postoperatively). 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?
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 18 Feb 2026; AzTrials last refreshed its copy on 30 Oct 2026.