- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07417319
Nursing Heat Therapy After Cholecystectomy (nursing)
Effects Of Nursing-Led Local Heat Application To The Feet On Postoperative Pain And Abdominal Distension After Cholecystectomy: A Randomised Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Efeler
-
Aydin, Efeler, Turkey (Türkiye), 09100
- Aydın Adnan Menderes University Faculty of Nursing
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Had undergone laparoscopic cholecystectomy,
- American Society of Anesthesiologists (ASA) physical status classification of I-II.
Exclusion Criteria:
- Had any neurological or psychiatric disorders,
- Conditions that could interfere with heat perception,
- Contraindications to foot heat application,
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Local Heat Therapy Group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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.
|
6, 12, 24, and 48 hours postoperatively.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ADU Nursing Faculty
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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