NCT06725316

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable pain

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

November 30, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 10, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

December 10, 2024

Status Verified

December 1, 2024

Enrollment Period

4 months

First QC Date

October 10, 2024

Last Update Submit

December 4, 2024

Conditions

Keywords

4-7-8 breathing exercisesgynaecological surgerypaincomplicationvital signs

Outcome Measures

Primary Outcomes (2)

  • vital signs assessment form

    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

    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.

Study Arms (2)

control group

NO INTERVENTION

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 Group

EXPERIMENTAL

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

Interventions

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.

Experimental Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Canan Uçakcı Asalıoğlu, dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 10, 2024

First Posted

December 10, 2024

Study Start

November 30, 2024

Primary Completion

March 30, 2025

Study Completion

March 30, 2025

Last Updated

December 10, 2024

Record last verified: 2024-12