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Completed

NCT Number: NCT07417319

Nursing Heat Therapy After Cholecystectomy

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aydın Adnan Menderes University Faculty of Nursing

Aydin, Efeler, 09100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Local Heat Application

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study title

Effects Of Nursing-Led Local Heat Application To The Feet On Postoperative Pain And Abdominal Distension After Cholecystectomy: A Randomised Controlled Trial

Acronym: nursing

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Feb 18, 2026
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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