Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06892782

Effect of Hot Pack Application on Gastrointestinal Motility After Abdominal Surgery

Study Title:

The Effect of Hot Water Pack Application to the Lumbar Region on Gastrointestinal Motility in Postoperative Abdominal Surgery Patients

Study Type:

Interventional (Randomized Controlled Trial)

Study Design:

Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single-blind (Outcome Assessor) Primary Purpose: Supportive Care

Condition:

Postoperative Gastrointestinal Motility in Abdominal Surgery Patients

Interventions:

Experimental: Hot Water Pack Application Intervention: Application of a hot water pack (heated to 40-42°C) to the lumbar region for 20 minutes, three times a day, in the first 48 postoperative hours.

Purpose: To evaluate its effect on gastrointestinal motility and postoperative recovery.

Control: Routine Care Intervention: Standard postoperative care without hot water pack application.

Primary Outcome Measures:

Time to First Postoperative Gas (Hours) [Time Frame: Up to 72 hours]

Time to First Postoperative Stool (Hours) [Time Frame: Up to 72 hours] Time to Initiation of Oral Intake (Hours) [Time Frame: Up to 72 hours]

Secondary Outcome Measures:

Incidence of Postoperative Nausea and Vomiting (PONV) [Time Frame: Up to 72 hours] Severity of Abdominal Distension [Time Frame: Up to 72 hours]

Quality of Recovery-15 (QoR-15) Scale Score [Time Frame: Postoperative Days 1 and 3]

Gastrointestinal Symptom Rating Scale (GSRS) Score [Time Frame: Postoperative Days 1 and 3]

Eligibility Criteria:

Inclusion Criteria:

Abdominal surgery in the general surgery ward Age ≥ 18 years BMI between 18.50-24.99 kg/m² Able to communicate verbally Conscious, oriented, and willing to participate

Exclusion Criteria:

Previous gastrointestinal surgery Postoperative complications History of small bowel resection, ileostomy, or colostomy History of inflammatory bowel disease, emergency surgery, neoadjuvant therapy, appendectomy Chronic opioid use Chronic constipation (≤ 2 bowel movements per week) Abdominal radiotherapy ICU admission or postoperative bleeding

Estimated Enrollment:

80 participants (40 intervention, 40 control)

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This study is a randomized controlled experimental design aimed at evaluating the effect of hot water pack application to the lumbar region on gastrointestinal motility (time to first postoperative gas, first stool, and initiation of oral intake) in patients undergoing abdominal surgery. The study will be conducted in the postoperative period.

Participants

The study will include patients who undergo abdominal surgery in the general surgery ward. Participants will be randomly assigned to one of two groups:

Intervention Group (Hot Water Pack Application) Control Group (Routine Care) Interventions

Intervention Group (Hot Water Pack Application):

Procedure: A hot water pack will be applied to the lumbar region for 20 minutes, three times a day during the first 48 postoperative hours. The hot water packs will be heated to a temperature of 40-42°C.

Purpose: To assess its effect on postoperative gastrointestinal motility (e.g., first gas, first stool, initiation of oral intake).

Control Group (Routine Care):

Procedure: Participants will receive standard postoperative care, which includes usual practices for abdominal surgery recovery without hot water pack application.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

18 years of age or older

Undergoing elective surgery

ASA I and III (American Society of Anesthesiologists physical status classification)

In the postoperative period, pulse, blood pressure, and body temperature within normal limits

Patients without previous gastrointestinal system surgery

Exclusion criteria

Previous gastrointestinal tract surgery

Complications in the postoperative period

History of small bowel resection and ileostomy or colostomy

History of inflammatory bowel diseases, emergency surgery, neoadjuvant therapy, appendectomy surgery

Chronic opioid use

Experiencing chronic constipation (≤ 2 bowel movements per week)

Receiving abdominal radiotherapy

Patients admitted to intensive care unit and patients with bleeding

Treatment and study plan

Hot Water Pack Application

Other

A hot water pack heated to 40-42°C will be applied to the lumbar region of the patient for 20 minutes at three intervals per day during the first 48 hours post-surgery.

Primary outcomes

  1. bowel motility

    Time frame: postoperative 1-3 day

    Gastrointestinal Symptom Rating Scale (GSRS) - Scale Scores The Gastrointestinal Symptom Rating Scale (GSRS) is a validated tool used to assess the severity of gastrointestinal (GI) symptoms. It consists of 15 items, each scored on a 7-point Likert scale (1 = no discomfort, 7 = severe discomfort).

    Scoring Interpretation:

    Total Score Range: 15 to 105 (higher scores indicate worse GI symptoms). Mean score calculation: Total score is divided by the number of items (15) to determine the severity of symptoms.

    GSRS Subdimensions:

    The GSRS evaluates five symptom clusters:

    Reflux (2 items) → Heartburn, regurgitation Abdominal pain (3 items) → Stomach pain, hunger pain, nausea Indigestion (4 items) → Bloating, burping, early satiety, stomach rumbling Diarrhea (3 items) → Loose stools, urgency, frequency Constipation (3 items) → Hard stools, straining, incomplete evacuation

    Interpretation of Scores:

    15 - 30 → Mild symptoms 31 - 60 → Moderate symptoms 61 - 105 → Severe symptoms

Study contacts

Contact information is provided by the study sponsor or research team.

Dilek TALHAOĞLU, assistant professor

CONTACT

[email protected]

+905545911691

Gülseren Maraş Baydoğan

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Collaborators

  • Kirsehir Ahi Evran Universitesi

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 25, 2025
Registry last updated
Mar 25, 2025

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.

Published trials that share one or more normalized conditions with this study.