NCT06294717

Brief 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. 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.

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
2

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Mar 2024

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

February 24, 2024

Last Update Submit

March 2, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Beck Anxiety Scale

    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)

  • Visual Analog Scale (VAS)

    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.

Study Arms (2)

Experimental Group

EXPERIMENTAL

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 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.

Other: Progressive relaxation exercises will be applied.

Control Group

NO INTERVENTION

No 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.

Interventions

Progressive relaxation exercises will be not applied.

Experimental Group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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,

You may not qualify if:

  • \. 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.

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

Study Design

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

Study Record Dates

First Submitted

February 24, 2024

First Posted

March 5, 2024

Study Start

March 1, 2024

Primary Completion

August 1, 2024

Study Completion

December 1, 2024

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share