Effect of Hot Pack Application on Gastrointestinal Motility After Abdominal Surgery

NCT06892782 | Not Yet Recruiting

• 1 other identifier: hot pack in abdominal surgery
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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)

Conditions

Abdominal Surgery

Outcome Measures

Primary Outcomes (1)

• bowel motility

  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

  postoperative 1-3 day

Study Arms (2)

Hot Water Pack Application

EXPERIMENTAL

Patients in the intervention group will receive hot water pack application to the lumbar region. After the surgery, a hot water pack (heated to 40-42°C) will be applied to the lumbar region of the patient for 20 minutes, three times a day during the first 48 postoperative hours. The goal is to assess the effect of this intervention on gastrointestinal motility, including the time to first postoperative gas, first stool, and initiation of oral intake.

Other: Hot Water Pack Application

Routine Care

NO INTERVENTION

Patients in the control group will receive routine postoperative care as per standard clinical practices. This group will not receive hot water pack application, and will instead undergo the usual procedures followed in the postoperative period to support recovery after abdominal surgery.

Interventions

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.

Hot Water Pack Application

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead
• Kirsehir Ahi Evran Universitesi: collaborator

Central Study Contacts

Dilek TALHAOĞLU, assistant professor

CONTACT

+905545911691; dilektalhaoglu@gmail.com

Gülseren Maraş Baydoğan

CONTACT

gulserenmaras@erciyes.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: March 9, 2025
• First Posted: March 25, 2025
• Study Start: March 15, 2025
• Primary Completion: November 15, 2025
• Study Completion: December 15, 2025
• Last Updated: March 25, 2025

Record last verified: 2025-03