NCT07384637

Brief Summary

Effects of Progressive Relaxation Exercises and Planned Training after Cesarean Section on Pain, Anxiety and Comfort

Trial Health

87
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
Last Updated

February 17, 2026

Status Verified

January 1, 2023

Enrollment Period

12 months

First QC Date

January 27, 2026

Last Update Submit

February 13, 2026

Conditions

Keywords

CaesareanPainAnxietyComfortExerciseEducation

Outcome Measures

Primary Outcomes (3)

  • Visual Analog Scale

    The scale is graded as 0-10 cm long, with 0=no pain, 10=the most severe pain. It is applied by the individual marking a point corresponding to the level of pain they feel. The distance between the determined point and the lowest part of the line is evaluated in centimeters. The value found indicates the patient's pain level.

    baseline

  • State-Trait Anxiety Inventory

    The State Anxiety Inventory consists of 20 items and requires individuals to describe how they feel at a specific moment under specific circumstances, taking into account their feelings about the situation. The Trait Anxiety Inventory also consists of 20 items and requires individuals to describe how they feel in a given situation, regardless of the circumstances. High scores on both the State and Trait Anxiety Inventories indicate high anxiety levels, while low scores indicate low anxiety levels.The scale allows for scores ranging from a minimum of 20 to a maximum of 80.

    Baseline

  • Postpartum Comfort Scale

    The Postpartum Comfort Scale assesses the physical, psychospiritual, and sociocultural comfort of women who have had both cesarean and vaginal deliveries. Physical and bodily perceptions constitute the physical comfort subscale. Spiritual and psychological components form the psychospiritual comfort subscale. Interpersonal, family, and social relationships, as well as components related to finances and support systems, constitute the sociocultural comfort subscale. The scale, which uses a five-point Likert scale, consists of 34 items. The lowest possible score is 34, and the highest is 170. Values close to 170 indicate a high level of comfort.

    Baseline

Secondary Outcomes (3)

  • Visual Analog Scale

    On the second postoperative day after a cesarean section

  • State-Trait Anxiety Inventory

    On the second postoperative day after a cesarean section

  • Postpartum Comfort Scale

    On the second postoperative day after a cesarean section

Study Arms (3)

Progressive Relaxation Exercises after Cesarean Section

EXPERIMENTAL

Progressive relaxation exercises began with breathing exercises, continued with muscle relaxation exercises, and lasted 30 minutes. Before starting the exercise, the environment was made quiet and free from external disturbances. The patient was also seated comfortably, and standard meditation music was played during the exercise. Progressive relaxation exercises combine the contraction and relaxation of large muscle groups such as the face, arms, legs, neck, and back with deep breathing. The exercises were performed by taking a deep breath, tensing the muscles, maintaining this tension for 5-7 seconds, and then relaxing the muscles (15-20 seconds). Throughout the exercise, the individual was instructed to continue breathing slowly and deeply through the nose and exhaling through the mouth.

Behavioral: Progressive Relaxation Exercise group

Planned Training after Cesarean Section

EXPERIMENTAL

The training group received pre-planned training based on the literature. The training content included topics such as postpartum uterine changes, bleeding and vaginal discharge, elimination, sleep and rest, postpartum blues, medication use, initiation of sexual intercourse, timing of the resumption of menstruation, contraceptive methods, nutrition, breast care and breast problems, infant care, breastfeeding, and infant vaccinations. During the training, educational materials such as illustrated guides on family planning were used, and an educational brochure prepared by the researcher based on the literature was also given to the women after the training. The training was conducted face-to-face with each woman by the researcher, in accordance with adult education principles, and lasted 30-45 minutes. In addition, training methods such as lecturing, question-and-answer, discussion, brainstorming, and problem-solving were used during the training.

Behavioral: Planned Education group

Standard of care Group

NO INTERVENTION

The control group received no treatment. They only received standard hospital care procedures along with the Visual Analog Scale, State-Trait Anxiety Inventory, and Postpartum Comfort Scale (pre-test, post-test).

Interventions

On the first postoperative day, the women were met with, informed, and their written consent was obtained. Women in the Planned Education group who met the inclusion criteria were administered the Personal Information Form, Visual Analog Scale, State-Trait Anxiety Inventory, and Postpartum Comfort Scale via face-to-face interviews on the first day. Completing all forms took 15-20 minutes. The training was conducted face-to-face by the researcher for each woman, in accordance with adult education principles, and lasted 30-45 minutes.

Planned Training after Cesarean Section

On the first postoperative day, the women were met with, informed, and their written consent was obtained. Women in the Progressive Relaxation Exercise group who met the inclusion criteria were administered the Personal Information Form, Visual Analog Scale, State-Trait Anxiety Inventory, and Postpartum Comfort Scale via face-to-face interviews on the first postoperative day. Completing all forms took 15-20 minutes. Relaxation exercises began with breathing exercises, continued with muscle relaxation exercises, and lasted 30 minutes. In the final test phase, the Visual Analog Scale, State-Trait Anxiety Inventory, and Postpartum Comfort Scale were repeated on the second postoperative day.

Progressive Relaxation Exercises after Cesarean Section

Eligibility Criteria

Age19 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • on the first postoperative day,
  • at least four hours after analgesic administration,
  • mobilized,
  • with their baby present,
  • their baby without any health problems,
  • without any physical or mental illness,
  • without communication problems,
  • who volunteered to participate were included in the study.

You may not qualify if:

  • women who were not present on the first postoperative day,
  • had not received analgesic treatment for at least four hours,
  • were not mobile,
  • did not have their baby with them,
  • their baby had any health problems,
  • they had a physical or mental illness,
  • they had difficulty communicating,
  • they did not volunteer to participate were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sivas Cumhuriyet University

Sivas, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainAnxiety DisordersMotor Activity

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBehavior

Study Officials

  • Sukran Ertekin Pinar, Prof. Dr.

    Cumhuriyet University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

January 27, 2026

First Posted

February 3, 2026

Study Start

January 1, 2023

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

February 17, 2026

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations