Clinical trial NCT06725316: The Effect Of 4-7-8 Breathıng Exercıs After Laparoscopıc Surgery
Official title: The Effect Of 4-7-8 Breathıng Exercıses on Paın, Vıtal Sıgns and Development ff Complıcatıons After Laparoscopıc Gynaecologıcal Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain
Keywords: 4-7-8 breathing exercises
gynaecological surgery
pain
complication
vital signs
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Primary outcomes:
measure: vital signs assessment form
timeFrame: post-op will be evaluated 4 times in total, at two, four, six, eight hours.
measure: Mcgill Pain Scale Short Form
timeFrame: post-op will be evaluated 4 times in total, at two, four, six, eight hours.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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