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Not yet recruiting NCT06725316

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

No phase Interventional Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 4-7-8 breathing exercises.
Who it may be relevant to
Registry conditions: Pain. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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.

Interventions

  • 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.

Primary outcome measures

  • vital signs assessment form [Time frame: 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06725316 · CUA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗