Pranayama and Deep Breathing Exercises Sleep Quality After Laparoscopic Cholecystectomy

July 8, 2024 updated by: Elif Kurt, Ataturk University

"The Effect of Pranayama and Deep Breathing Exercises on Shoulder Pain and Sleep Quality After Laparoscopic Cholecystectomy"

This study explores the impact of pranayama and deep breathing exercises on alleviating shoulder pain and improving sleep quality following laparoscopic cholecystectomy.

Study Overview

Detailed Description

The data were collected by the researcher by face-to-face interview method at SBU Van Training and Research Hospital General Surgery Clinics. Necessary information was given to healthcare professionals in the clinics where the research would be conducted, and the lists of patients who would undergo surgery were followed. Data collection started in the preoperative period, and the data collection phase ended when the patient was discharged after the surgery.

To collect pranayama, deep breathing and control group data, the researcher identified patients who were scheduled to undergo laparoscopic cholecystectomy surgery in general surgery services on a daily basis and met the sampling criteria. In the hospital where the research was conducted, laparoscopic cholecystectomy surgeries were performed excluding emergency surgeries.

It is performed electively and patient education is provided on the day of surgery. Patients are taken into surgery according to the surgery list determined the day before.

It was determined by randomization whether the patients participating in the study would be in the control or experimental groups. Patients were included in the study according to randomization order. Patients coming for surgery were randomly assigned to a pranayama group, a deep breathing group, and a control group.

This randomization technique was continued until the sample number in the research groups was reached, and the study was terminated when 22 patients were included in the pranayama group, 22 in the deep breathing group and 22 in the control group.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Erzurum, Turkey, 25240
        • Ataturk University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Shoulder pain after elective laparoscopic cholecystectomy surgery patients,
  • No hearing-speech problems that would hinder communication,
  • No cognitive-mental problems,
  • Not having any psychiatric disease,
  • No sleep disorder
  • Patients who have not previously attended courses on breathing exercises and yoga,
  • All volunteers who agreed to participate in the study were included in the study.

Exclusion Criteria:

  • Admitted to the intensive care unit in the early postoperative period,
  • Extra surgical intervention (hernia repair, etc.),
  • During laparoscopic cholecystectomy, patients undergoing open cholecystectomy patients were excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pranayama-
Patients will perform breathing exercises every two hours from the 4th hour after surgery until discharge. Then, their pain will be evaluated with the Visual analog scale before and after exercise at the 6th hour, 12th hour, 24th hour and at discharge.
Pain of patients will be evaluated with the Visual analog scale at the 6th hour, 12th hour, 24th hour and at discharge.
Other Names:
  • PRANAYAMA
Experimental: deep breathing -
Patients will perform breathing exercises every two hours from the 4th hour after surgery until discharge. Then, their pain will be evaluated with the Visual analog scale before and after exercise at the 6th hour, 12th hour, 24th hour and at discharge.
Pain of patients will be evaluated with the Visual analog scale at the 6th hour, 12th hour, 24th hour and at discharge.
Experimental: control
Patients will not undergo any postoperative intervention. Then, their pain will be evaluated with the Visual analog scale at the 6th hour, 12th hour, 24th hour and at discharge.
Pain of patients will be evaluated with the Visual analog scale at the 6th hour, 12th hour, 24th hour and at discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of pain after laparoscopic cholecystectomy with visual analogue scale in deep breathing group, pranayama group and control groups.
Time Frame: Pain was evaluated before surgery. After surgery, pain was evaluated before and after exercise, at the 6th hour, 12th hour, 24th hour and at discharge.
On the visual analogue scale, 0 points mean no pain, and 10 points mean unbearable pain.
Pain was evaluated before surgery. After surgery, pain was evaluated before and after exercise, at the 6th hour, 12th hour, 24th hour and at discharge.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of sleep of patients after laparoscopic cholecystectomy with the Richard Campbell Sleep Scale
Time Frame: The sleep quality of the patients was measured before the surgery and in the morning of the second day of the surgery.
Sleep is evaluated on a chart between 0 and 100. A score between "0-25" from the scale indicates very poor sleep, and a score between "76-100" indicates very good sleep.
The sleep quality of the patients was measured before the surgery and in the morning of the second day of the surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

July 1, 2024

Study Registration Dates

First Submitted

June 10, 2024

First Submitted That Met QC Criteria

July 8, 2024

First Posted (Actual)

July 10, 2024

Study Record Updates

Last Update Posted (Actual)

July 10, 2024

Last Update Submitted That Met QC Criteria

July 8, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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