Information and Progressive Relaxation Exercises

NCT06708585 | Recruiting

• 1 other identifier: NIGDE OMER HALISDEMIR UNIVERSI
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

This study was planned to determine the effect of information and progressive relaxation exercises before planned cesarean section on surgical fear, anxiety, postpartum comfort and pain levels.The research will be conducted in experimental design. The research will begin after receiving written permission from Niğde Ömer Halisdemir University Ethics Committee, Niğde Provincial Health Directorate and Ömer Halisdemir Training and Research Hospital. Pregnant women who are between the ages of 18-35, who are on Primigravida, who apply for a planned cesarean section, who have a live single pregnancy, and who are planned for spinal anesthesia will be included in the study. Before starting the research, the study will begin by obtaining institutional permissions and written permission from the pregnant women. Pre-Assessment Form, Personal Information Form, State Anxiety Scale, Surgical Fear Scale, Postpartum Comfort Scale will be used to collect data. The data will be evaluated on a computer using the IBM SPSS Statistics 24 (Statistical Package for the Social Sciences for Windows) package program. Appropriate statistical analyzes will be used to evaluate the data.

Conditions

Caesarean Section; Fear; Anxiety; Pain

Keywords

Cesarean section, fear, anxiety, comfort, pain

Outcome Measures

Primary Outcomes (2)

• State Anxiety Scale

  It is understood that as the score obtained from the scale increases, anxiety increases.

  3 month

• Surgical Fear Scale

  a high score indicates that surgical fear is high

  3 month

Secondary Outcomes (2)

• Visual Analog Scale (VAS)

  3 month

• postpartum comfort scale

  3 month

Study Arms (2)

Experimental group

EXPERIMENTAL

Each pregnant woman who meets the inclusion criteria will be interviewed individually for approximately 15-20 minutes on the day of surgery and data collection forms will be applied. Then, each woman will be given progressive relaxation exercises individually. Exercises will begin two hours before surgery and will be repeated four times. Each exercise will last approximately 20 minutes. Data collection forms will be applied two hours after the completion of the exercise and at the end of surgery.

Other: progressive relaxation exercises and training

control group

NO INTERVENTION

Each pregnant woman in the control group will be administered the individual information form, State Anxiety Scale, and Surgical Fear Scale data collection tools two hours before the surgery and will be released to the routine care of the institution. After two hours, the State Anxiety Scale and Surgical Fear Scale will be administered again. 6 hours after the cesarean section, the woman's pain will be assessed with the VAS pain scale and 24 hours later, the postpartum comfort scale will be administered.

Interventions

progressive relaxation exercises and training OTHER

Considering the high incidence of cesarean section and the prevalence of anxiety and fear as psychological symptoms, providing comfort and pain support to women is of great importance. Therefore, the effect of progressive relaxation exercise and education before cesarean section surgery on care outcomes will be determined.

Experimental group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: primigravida women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between the ages of 18-35,
• Primigravida,
• Applied for planned cesarean section,
• Live singleton pregnancy,
• Spinal anesthesia planned,

You may not qualify if:

• Women who develop postpartum maternal or neonatal complications
• Receiving general anesthesia.

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead

Study Sites (1)

Ömer Halisdemir University Training and Research Hospital

Niğde, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• birnur YEŞİLDAĞ, Dr

  Ömer Halisdemir University

  STUDY DIRECTOR

Central Study Contacts

BİRNUR YEŞİLDAĞ, Dr

CONTACT

05336815923; nurumbirnur@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The research is a two-group parallel randomized controlled experimental study.

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: November 27, 2024
• Study Start: September 19, 2024
• Primary Completion: February 20, 2025
• Study Completion: March 30, 2025
• Last Updated: November 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)