PainNCT06725316
The Effect Of 4-7-8 Breathıng Exercıs After Laparoscopıc Surgery
A study testing 4-7-8 breathing exercises in people with Pain, run by Gazi University.
Trial summary
The study was a single-centre, parallel randomised controlled experimental study conducted with block randomisation method. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain
- What is being tested?
- 4-7-8 breathing exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2024to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain
- Being tested
- 4-7-8 breathing exercises
- Keywords
- 4-7-8 breathing exercises, gynaecological surgery, pain, complication, vital signs
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-7-8 breathing exercisesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: 4-7-8 breathing exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: post-op will be evaluated 4 times in total, at two, four, six, eight hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start30 Nov 2024 (estimated)
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Canan Uçakçı Asalıoğlu, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725316
- Sponsor's protocol ID
- CUA
- Status last verified
- Dec 2024
- First submitted
- 10 Oct 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of 4-7-8 Breathıng Exercıses on Paın, Vıtal Sıgns and Development ff Complıcatıons After Laparoscopıc Gynaecologıcal Surgery
- ClinicalTrials.gov ID
- NCT06725316
- Acronym / sponsor ID
- CUA
- Conditions
- Pain
- Keywords
- 4-7-8 breathing exercises, gynaecological surgery, pain, complication, vital signs
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 30 Nov 2024 (estimated)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: 4-7-8 breathing exercisesThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4-7-8 breathing exercisesSteps 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. | Behavioural | Experimental Group |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing 4-7-8 breathing exercises in people with Pain, run by Gazi University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Canan Uçakcı Asalıoğlu, dr. (+903122022685, cananucakci2001@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vital signs assessment form (time frame: post-op will be evaluated 4 times in total, at two, four, six, eight hours.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.