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NCT Number: NCT06725316

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

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

4-7-8 breathing exercises

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Study contacts

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

Canan Uçakcı Asalıoğlu, dr.

CONTACT

[email protected]

+903122022685

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 10, 2024
Registry last updated
Dec 10, 2024

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.

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