The Effect Of 4-7-8 Breathıng Exercıs After Laparoscopıc Surgery

December 4, 2024 updated by: Canan Uçakçı Asalıoğlu, Gazi University

The Effect Of 4-7-8 Breathıng Exercıses on Paın, Vıtal Sıgns and Development ff Complıcatıons After Laparoscopıc Gynaecologıcal Surgery

The study was a single-centre, parallel randomised controlled experimental study conducted with block randomisation method.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

In determining the sample of the research, power analysis was performed and it was planned to have a total of 62 participants, with 31 participants in each group.Women undergoing gynaecological operations will be recruited in the order of hospitalisation according to the block randomisation method. The letters A and B in the blocks will be determined as experimental or control according to the coin flip method. One of the researchers will evaluate the participants according to the inclusion criteria and randomly assign them according to the block order after obtaining their informed consent. One of the researchers in this study will carry out the application. The other researchers will be blinded. The data obtained will be analysed by an independent statistician. Participant blinding will not be performed since the participants were informed about the study in informed consent. Descriptive Information Form, Mcgill Pain Scale Short Form (Biçici, 2010) and Vital Signs Assessment Form to evaluate vital signs and mobilisation will be used for data collection.Women who applied to the hospital due to benign gynaecological disorders and underwent laparoscopic surgery will first be evaluated whether they are eligible for the study according to the inclusion criteria evaluation form. Afterwards, women who are eligible to participate in the study will be randomly assigned by an independent researcher to determine whether they are in the experimental or control group.

Study Type

Interventional

Enrollment (Estimated)

62

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 Contact

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

No

Description

Inclusion Criteria:

Being literate, Having benign gynaecological disease, Not having any other disease affecting pain/living findings (neuropathy, migraine, Cardiovascular diseases, oncological disease, ...), Not using painkillers regularly, Not having substance addiction, Not having communication barrier.

Exclusion Criteria:

It was determined that women did not perform 4-7-8 breathing exercises regularly, Women wanted to leave the study, Complications related to surgery occurred at any stage of the study, Women did not complete the data collection tools.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
Women in the control group will receive routine care in the hospital. Vital signs assessment form will be used to evaluate vital signs and development of complications in the first 8 hours of the postoperative period. The 'Mcgill Pain Scale Short Form' form will be used to evaluate the pain of the patients and the pain of the patient will be evaluated 4 times in total, at two, four, six and eight hours post-op.
Experimental: Experimental Group

The women in the experimental group will be taught 4-7-8 breathing exercises before the operation. After making sure that they perform these exercises correctly, the training will be terminated. In order to perform the 4-7-8 exercise correctly and easily, an audible second counting application will be installed on the participants' phones and an hourly reminder alarm will be set. Participants will perform the first exercise with the postoperative nurse and the following exercises by themselves. Participants will be asked to do the exercise four times every hour for the first 8 hours postoperatively.

Vital signs assessment form will be used to evaluate vital signs and development of complications in the first 8 hours postoperatively. The 'Mcgill Pain Scale Short Form' form will be used to evaluate the pain of the patients and the patient's pain will be evaluated 4 times in total, at two, four, six and eight hours post-op.
Behavioral: 4-7-8 breathing exercises
Steps of doing 4-7-8 breathing exercise; firstly, the breath taken is exhaled completely through the mouth as if whistling. Then the lips are closed and inhaled quietly through the nose (4 seconds). The breath is held for seven seconds. At the last stage, the lips are tightened and exhaled through the mouth for 8 seconds. Then normal breathing is done for one minute. Breathing is repeated four times every hour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vital signs assessment form
Time Frame: post-op will be evaluated 4 times in total, at two, four, six, eight hours.
It was created by the researchers and will be used to determine blood pressure, pulse rate, painkiller use and complication development status.
post-op will be evaluated 4 times in total, at two, four, six, eight hours.
Mcgill Pain Scale Short Form
Time Frame: post-op will be evaluated 4 times in total, at two, four, six, eight hours.
The Short Form of the McGill Pain Scale consists of three parts.As the scores increase in this scale, it is seen that the pain level increases.
post-op will be evaluated 4 times in total, at two, four, six, eight hours.

Collaborators and Investigators

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

Sponsor

Gazi University

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 (Estimated)

November 30, 2024

Primary Completion (Estimated)

March 30, 2025

Study Completion (Estimated)

March 30, 2025

Study Registration Dates

First Submitted

October 10, 2024

First Submitted That Met QC Criteria

December 4, 2024

First Posted (Estimated)

December 10, 2024

Study Record Updates

Last Update Posted (Estimated)

December 10, 2024

Last Update Submitted That Met QC Criteria

December 4, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CUA

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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