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PainNCT06294717

The Effect of Progressive Relaxation Exercises on Physiological Parameters, Pain and Anxiety After Cesarean Section

A study testing Progressive relaxation exercises will be applied. in people with Pain, run by Ataturk University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Caesarean section is a surgical procedure that can be performed before or during birth in cases where the life of the mother and fetus is threatened or upon the request of the mother and father. One of the most common problems after cesarean section is abdominal pain. Read more about this study

Who is it for?
Ages 20 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pain
What is being tested?
Progressive relaxation exercises will be applied.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
No sites listed yet
Study dates
1 Mar 2024to 1 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

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 20 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Being between the ages of 20-35,
  • Primiparous pregnancy
  • Having a transverse cesarean section,
  • It should be taken at the 8th hour postoperatively: since mobilization occurs at the 6th hour after the surgery, it should be taken from the 8th hour postoperatively to prevent fatigue in the woman's extremities and to avoid any health problems (nausea-vomiting, headache-waistache) that prevent her from doing the exercises.
  • Primary school graduate,
  • No mental disability or communication problems. Exclusion criteria;
  • 1. Those who have an open wound on their body and/or a diagnosis of allergic disease on their skin, 2. Puerperal complications (bleeding, infection, fever), 3. Those with cardiac arrhythmia and a pacemaker, 4. At risk of experiencing convulsions; Those with diseases such as eclampsia and epilepsy, 5. Those with kidney or liver disease, 6. Those who have practiced progressive relaxation exercises before, 7. Morbidly obese (BKI over 40), 8. Women using chronic opioids, antidepressants, and psychoactive drugs were not included in the study.

Who cannot join

None listed.

Trial locations and contacts

No sites are listed yet.

About this study

Caesarean section is a surgical procedure that can be performed before or during birth in cases where the life of the mother and fetus is threatened or upon the request of the mother and father. One of the most common problems after cesarean section is abdominal pain. Progressive relaxation exercises are a method that allows certain muscle groups in the body to first contract and then relax. Progressive relaxation exercises have been proven to have positive effects on anxiety. By applying progressive relaxation exercises, the parasympathetic nervous system is activated; Thus, heart and respiratory rate and blood pressure can be kept within normal limits. This study will be conducted to determine the physiological parameters, pain and anxiety levels of progressive relaxation exercises, one of the non-pharmacological methods, on women giving birth by cesarean section.

Read the detailed description

Purpose of the research: (Must be clearly stated and compatible with the subject title) It will be carried out as a randomized controlled experimental design to determine the effect of progressive relaxation exercises on physiological parameters, pain and anxiety after cesarean section.

  1. Materials and methods of the research: Type of Study: This research is a randomized controlled study.

Research Questions/Hypotheses:

Hypothesis 1 (H1): Progressive relaxation exercises after cesarean section have an effect on physiological parameters.

Hypothesis 2 (H1): Progressive relaxation exercises after cesarean section have no effect on physiological parameters.

Hypothesis 3 (H2): Progressive relaxation exercises have an effect on pain after cesarean section.

Hypothesis 4 (H2): Progressive relaxation exercises have no effect on pain after cesarean section.

Hypothesis 5 (H3): Progressive relaxation exercises after cesarean section have an effect on anxiety.

Hypothesis 6 (H3): Progressive relaxation exercises have no effect on anxiety after cesarean section.

Location and Characteristics of the Research: The research will be conducted between September 1, 2023 and August 1, 2024, in the gynecology service of Şanlıurfa Training and Research Hospital, with women who gave birth by cesarean section and meet the inclusion criteria. This hospital was chosen due to its nature as a regional hospital and the density of cesarean births.

Population-sample of the research: The population of this research will consist of women who gave birth by cesarean section in the gynecology service of Şanlıurfa Training and Research Hospital between February 1, 2024 and August 1, 2024, 2024. Taking into account the tests to be used to calculate the minimum sample size to be included in the study, GPower analysis was performed and the sample size was calculated as 120 puerperal mothers. A total of 120 postpartum women will be included in the sampling, including 60 postpartum women who meet the inclusion criteria for the study, who agree to participate in the study, and who gave birth by cesarean section to which progressive relaxation exercises are applied, and 60 postpartum women who give birth by cesarean section to which progressive relaxation exercises are not applied.

Data Collection Forms and Tools:

Postpartum Identification Form:

This form was prepared and developed by the researchers based on the literature. It consists of questions to determine sociodemographic, medical and obstetric characteristics.

Beck Anxiety Scale: Developed by Beck et al. in 1988, the scale measures the frequency of anxiety symptoms experienced by a person. The person is asked to indicate how much the listed anxiety symptoms bother him or her in the last week. The scale, consisting of twenty-one items, provides a four-point Likert type measurement (0 being not at all, 3 being seriously). It was used in the study to evaluate the overlap validity of typical anxiety symptoms. Turkish validity and reliability study was conducted by Ulusoy, Şahin and Erkmen in 1998. The scale consists of items containing somatic symptoms and subjective anxiety. (Cronba alpha value=0.93)

Visual Analog Scale (VAS):

It is a pain level measurement method created by Albersnagel (1988). It is used to make the undetermined feeling of pain numerically meaningful. The validity and reliability study in our country was conducted by Aydin et al. (2011). The range of 0 (zero) and 10 cm is determined on a ruler. 0 (zero) means "no pain" and 10 means "worst possible pain". The patient is asked to mark the place that expresses his pain on the line. The distance marked by the patient is measured by taking the zero starting distance. The benefit of the Visual Comparison Scale is that it is a proven scale and has been shown to be sensitive to changes in a patient's pain experience. It is quick to use and relatively easy to understand for most patients. It avoids the misuse of descriptive words to describe pain and allows meaningful comparison of measurements over time.

Physiological Parameters:

Physiological Measurements Form; vital signs of the woman giving birth; It is a chart where pulse, respiration, systolic blood pressure, diastolic blood pressure and oxygen saturation are recorded.

Progressive Relaxation Exercises: All muscles in the body contract and relax in a coordinated manner. Progressive relaxation exercises, which have been studied in cancer pain, for symptom control in cancer patients receiving chemotherapy, for improving nausea and vomiting after chemotherapy, and for improving quality of life, have been adopted to reduce anxiety, pain, and other stress symptoms, and to increase mental health. The exercise involves systematically tensing and relaxing our muscles. In this way, the exact location of the muscles and their state of tension are known.

Collection of Data:

The data will be obtained from postpartum women who gave birth by cesarean section in the gynecology service of Şanlıurfa Training and Research Hospital and meet the sample selection criteria. Before the application, an explanation will be given to the postpartum women about the purpose of the research, and if they volunteer, their verbal and written permission will be obtained through the "Informed Volunteer Consent Form". Information about postpartum women will be collected by the researcher.

Application of Research

Experimental Group:

Postpartum women will be informed about the research and their written and verbal permissions will be obtained.

Information about postpartum women will be recorded. Women who gave birth by cesarean section who agree to participate in the study will be assigned to 2 groups by randomization method: experimental (group to which progressive relaxation exercises will be applied) and control (group to which progressive relaxation exercises will not be applied).

Progressive relaxation exercises will be explained and taught to the puerperant after cesarean section. Experimental Group (in the group where progressive relaxation exercises were applied); The first application will be made at the 8th postoperative hour. Before the application, the Puerperal Identification Form, Beck Anxiety Scale, Visual Analogue Scale (VAS) and Physiological Parameters forms will be filled out. Starting from the 8th post-op hour, the second and third application will be made eight hours apart within a 48-hour period. On the second day, progressive relaxation exercises will be performed once, twice and three times at eight-hour intervals. At the end of the second day, the Postpartum Definition Form, Beck Anxiety Scale, Visual Analogue Scale (VAS) and Physiological Parameters forms will be filled in again (posttest).

The patient is placed in a supine position. First, the right palm is placed just below the navel, the left hand is placed on the chest and the eyes are closed.

Before inhaling, the lungs are emptied thoroughly by exhaling. When exhaling, the lungs should not be strained and the breath should come out on its own without being forced.

When you start breathing, the lung capacity is divided into two imaginary and the lung is filled completely by counting "one" and "two". Wait for a short time, count "one-two" and evacuate in twice the time you breathe. The right hand should feel the breastbones opening to the side, like a movable bridge31. Wait two seconds before taking another breath.

Take another deep breath and repeat the same process. After repeating slow and deep breathing exercises a few times, progressive relaxation exercises should be started.

In progressive relaxation exercises, all major muscles, in order from bottom to top; right foot, left foot, right leg, left leg, hip, abdominal muscles, back muscles, chest muscles, right hand, left hand, right arm, left arm, neck, shoulders and facial muscles contract while breathing slowly, then exhale It is released by loosening while giving After each muscle contraction and relaxation process, slow and deep breathing exercises should be performed 4-5 times in between before moving on to a new muscle group.

After the relaxation exercises are done and completed in all muscle groups, all muscles contract simultaneously while inhaling and relaxed simultaneously while exhaling. Then, the progressive relaxation exercise is completed with several deep breathing movements.

Control Group:

No application will be carried out with the participants in the control group. At the 8th postoperative hour, the Puerperal Identification Form, Beck Anxiety Scale, Visual Analogue Scale (VAS) and Physiological Parameters forms will be filled out. These participants will be asked not to engage in regular physical activity or sports for 2 days and not to make any changes in their living habits.

During the interview two days later, the Postpartum Identification Form, Beck Anxiety Scale, Visual Analogue Scale (VAS) and Physiological Parameters forms will be filled out again by the puerperant women.

Evaluation of Data

Evaluation of the data obtained as a result of the research will be analyzed using the SPSS (Statistical Package For Social Sciences) 25.0 package program.

Limitation of the Study: It is limited to women who gave birth by cesarean section at Şanlıurfa Training and Research Hospital affiliated with Şanlıurfa Provincial Health Directorate.

Ethical and Legal Aspects of Research Permission will be obtained from Atatürk University Clinical Research Ethics Committee before data collection. Institutional permission will be obtained from Şanlıurfa Provincial Health Directorate. Before the application, verbal and written consent will be obtained from women who gave birth by cesarean section through the "Informed Volunteer Consent Form", if they volunteer, by explaining the purpose of the research.

Conditions
Pain
Being tested
Progressive relaxation exercises will be applied.
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Progressive relaxation exercises will be applied.Other

    Progressive relaxation exercises will be not applied.

Study groups in NCT06294717
Study groupRoleWhat they receive
Experimental GroupExperimentalProgressive relaxation exercises will be explained and taught to the puerperant after cesarean section. Experimental Group (in the group where progressive relaxation exercises were applied); The first application will be made at the 8th postoperative hour. Before the application, the Puerperal Identification Form, Beck Anxiety Scale, Visual Analogue Scale (VAS) and Physiological Parameters forms will be filled out. Starting from the 8th post-op hour, the first, second and third applications will be made eight hours apart within a 48-hour period. On the second day, progressive relaxation exercises will be performed once, twice and three times at eight-hour intervals. At the end of the second day, the Postpartum Definition Form, Beck Anxiety Scale, Visual Analogue Scale (VAS) and Physiological Parameters forms will be filled in again.
Receives: Other: Progressive relaxation exercises will be applied.
Control GroupNo interventionNo application will be made with participants in the control group. At the 8th postoperative hour, the Puerperal Identification Form, Beck Anxiety Scale, Visual Analogue Scale (VAS) and Physiological Parameters forms will be filled out. These participants will be asked not to engage in regular physical activity or sports for 2 days and not to make any changes in their living habits. During the interview two days later, the Postpartum Identification Form, Beck Anxiety Scale, Visual Analogue Scale (VAS) and Physiological Parameters forms will be filled out again by the postpartum women.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Beck Anxiety Scale

    Measured: The first application (pretest) was performed at the eighth hour after surgery and The second application (posttest) will be applied at the end of two days.

Secondary outcomes (1)
  1. Visual Analog Scale (VAS)

    Measured: The first application (pretest) was performed at the eighth hour after surgery and The second application (posttest) will be applied at the end of two days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2024
  2. Study start1 Mar 2024 (estimated)
  3. Primary completion1 Aug 2024 (estimated)
  4. Study completion1 Dec 2024 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
2 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06294717
Sponsor's protocol ID
AtaturkUPhStudentNeslihanATLI
Status last verified
Mar 2024
First submitted
24 Feb 2024
Last updated
5 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Progressive relaxation exercises will be applied. in people with Pain, run by Ataturk 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 7 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 5 Mar 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Neslihan ATLI (05456330214, neslihanatli96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Beck Anxiety Scale (time frame: The first application (pretest) was performed at the eighth hour after surgery and The second application (posttest) will be applied at the end of two days.). 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 5 Mar 2024.

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