Incentive Spirometry Versus Massage Therapy Among Post Laparoscopic Cholecystectomy Patients

NCT07029477 | Completed DMC

• 1 other identifier: Spirometry Versus Massage
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to: Evaluate the effect of incentive spirometry versus massage therapy on the level of shoulder pain, and nausea among post laparoscopic cholecystectomy patients.

Conditions

Laparoscopic Cholecystectomy; Shoulder Pain; Nausea

Outcome Measures

Primary Outcomes (1)

• Shoulder Pain Level & Nausea

  Change in patient-reported shoulder pain and nausea using a Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain or nausea and 10 indicates the worst possible pain or nausea. Higher scores indicate worse outcomes.

  Within 12 hours post laparoscopic cholecystectomy

Study Arms (2)

Incentive Spirometry for Postoperative Pain and Nausea

EXPERIMENTAL

Participants in this group received incentive spirometry therapy only.

Device: Incentive Spirometry

Massage Therapy for Postoperative Pain and Nausea

EXPERIMENTAL

Participants in this group received massage therapy only.

Behavioral: Massage Therapy

Interventions

Incentive Spirometry DEVICE

Participants received incentive spirometry therapy using a standard device beginning within 2 hours post-laparoscopic cholecystectomy. They were instructed to take 10 deep breaths every 2 hours for 12 hours.

Incentive Spirometry for Postoperative Pain and Nausea

Massage Therapy BEHAVIORAL

Participants received manual massage therapy at regular intervals of 4, 8, and 12 hours after laparoscopic cholecystectomy.

Massage Therapy for Postoperative Pain and Nausea

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Both sexes.
• Patients aged between 20 to 60 years.
• Patients having the ability to communicate.
• Willing to participate in the study.

You may not qualify if:

• Patients who had postoperative bleeding.
• Patients who had postoperative hemodynamic disorders (severe elevation or reduction of blood pressure and shock).
• Patients who had postoperative complications requiring mechanical ventilation.
• Patients who had respiratory aspiration.
• Patients who had a history of drug abuse.
• Patients who had previous shoulder pain chronicity
• Uncooperative patients or patients unable to understand how to use the incentive spirometry device properly.
• Patients whose surgery converted from laparoscopic to open surgery

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Nursing. Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Shoulder Pain; Nausea

Interventions

Massage

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Amal Eid Abdel Moneim, Assist Professor

  Mansoura University

  STUDY DIRECTOR

• Wafaa Ismail Shereif, Professor

  Mansoura University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: quasi-experimental research design

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: June 19, 2025
• Study Start: April 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 30, 2024
• Last Updated: June 19, 2025

Record last verified: 2025-06

Locations

EG (1)