NCT04170569

Brief Summary

The objective of this study is to examine the effect of yoga on posttraumatic growth and quality of life. The birth action, which includes positive and negative experiences, can be an important opportunity to achieve posttraumatic growth and improve the quality of life. This is a experimental model with pretest-posttest control group study. Two hundred and fifty-two women who met the criteria for inclusion in the study made up the research population. Three instruments were used to obtain the research data: Personal Information Form, Posttraumatic Growth Inventory (PTGI) and SF-36 Quality of Life Questionnaire (SF-36).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 19, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 20, 2019

Completed
Last Updated

November 20, 2019

Status Verified

November 1, 2019

Enrollment Period

3 months

First QC Date

October 29, 2019

Last Update Submit

November 18, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • The Effect of Yoga on Posttraumatic Growth in the Postpartum Period

    The posttraumatic growth scale for measure posttraumatic growth;The scale is scored from 0 to 5 and the lowest is 0 and the highest is 105. The higher the scores obtained, the higher the approval from the traumatic experience shows that it is experiencing high growth. There are three sub-dimensions: the change in self-perception of the scale, the change in philosophy of life, and the change in relationship with others.

    10 weeks

  • The Effect of Yoga on Quality of Life in the Postpartum Period

    SF-36 Quality of life scale for measure the quality of life; The scale is calculated by inverting the items 1, 6, 7, 8, 9d, 9e, 9h, 11b, 11d. Total score is not calculated in the scale. The subscales evaluate health between 0-100 points. 0 indicates "poor health" and 100 indicates "good health.Higher scores obtained from the subscales of the scale indicate that the quality of life level is high.

    10 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

Yoga program was applied.

Behavioral: Yoga

Control Group

NO INTERVENTION

No yoga program.

Interventions

YogaBEHAVIORAL

Yoga Practice and Program: Yoga practice consisted of 10 weeks. Yoga practice involved following stages; 5-minute breathing exercises in standing or sitting position, 40-minute postpartum period specific asanas and last 15- minute deep relaxation in lying position were made by the researcher.

Experimental Group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsit is a study specific to postpartum period.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Having a baby between 2 and 6 months
  • First time mom
  • No tissue deformity in extremities

You may not qualify if:

  • Any gynecological disease
  • Any psychiatric illness
  • Using any psychiatric medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacer

Malatya, Battalgazi, 44100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: Randomized Controlled trial with a prospective pretest-posttest experimental model
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Inonu University

Study Record Dates

First Submitted

October 29, 2019

First Posted

November 20, 2019

Study Start

October 19, 2017

Primary Completion

January 19, 2018

Study Completion

January 19, 2019

Last Updated

November 20, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations