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Not yet recruiting NCT06896955

Effects of Virtual Reality Application and Progressive Relaxation Exercise

No phase Interventional Pregnancy Exercise Virtual Reality

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PMR+VR Education, PMR Education.
Who it may be relevant to
Registry conditions: Pregnancy, Exercise, Virtual Reality. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effects of Virtual Reality Application and Progressive Relaxation Exercise Training on Pregnant Women's Stress, Birth Affect and Birth Self-Efficacy

Overview

In the study, random assignment and randomization concealment will be applied to control selection bias. Pregnant women were assigned to groups by an independent statistician using the block randomization method. For this purpose, 6-digit combinations consisting of the letters "A", "B" and "C" were first created in the randomization of 78 women.

Detailed description

There will be three groups in the randomized experimental controlled study:PRE (Progressive Relaxation Exercise), VR (Virtual Reality)+PGR (Progressive Relaxation Exercise) and Control group. In order to carry out the application phase of the study, the responsible researcher participated in the training program on PRE and received a certificate on this subject. In addition, permission for the use of PRE Cd was obtained from the Turkish Psychologists Association to be used in the PRE group. The following procedures will be performed for pregnant women included in the study.

Interventions

  • Other PMR+VR Education
    PMR and VR education
  • Other PMR Education
    PMR education

Primary outcome measures

  • Pregnancy Stress Assessment Scale [Time frame: pre-intervention, after 2 month]
  • Birth Self-Efficacy Scale [Time frame: intervention after 2 month]
  • Birth Affect Scale [Time frame: intervention after 2 month]

Eligibility criteria

Inclusion criteria

  • Voluntary participation
  • No communication difficulties (no mental retardation, no visual/hearing impairment)
  • Knowing Turkish and being literate
  • No fetal anomalies
  • Being in the 32nd week of pregnancy
  • Not being diagnosed with a risky pregnancy (multiple pregnancy, premature rupture of membranes, preeclampsia, gestational diabetes, placenta previa, etc., pregnancies may end with a cesarean section)

Exclusion criteria

  • Having a psychiatric disease diagnosis

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Cukurova University — Adana

Identifiers

NCT: NCT06896955 · 01.09.2023/55

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗