NCT07417319

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

8 months

First QC Date

February 4, 2026

Last Update Submit

February 10, 2026

Conditions

Keywords

Nursing interventions; Non-pharmacological pain management

Outcome Measures

Primary Outcomes (2)

  • Abdominal Distension

    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

    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.

Study Arms (1)

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.

Other: Local Heat Application

Interventions

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.

Local Heat Therapy Group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Had undergone laparoscopic cholecystectomy,
  • American Society of Anesthesiologists (ASA) physical status classification of I-II.

You may not qualify if:

  • Had any neurological or psychiatric disorders,
  • Conditions that could interfere with heat perception,
  • Contraindications to foot heat application,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aydın Adnan Menderes University Faculty of Nursing

Aydin, Efeler, 09100, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: single-blind randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 4, 2026

First Posted

February 18, 2026

Study Start

February 3, 2025

Primary Completion

October 1, 2025

Study Completion

February 1, 2026

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to patient confidentiality and institutional ethical restrictions.

Locations