NCT06537570

Brief Summary

Physical changes that occur during pregnancy, transition to parenthood and taking on new responsibilities cause burden, anxiety and stress in women and negatively affect psychosocial health. One of the conditions that negatively affect psychosocial health during pregnancy is the fear of childbirth. One of the current methods used in the management of the pregnancy process is guided imagery.It is known that guided imagery practice reduces stress and anxiety in pregnant women, increases well-being and is beneficial to their daily lives, contributes positively to mother-baby attachment, and reduces pain in childbirth.

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 Jul 2022

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

July 20, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2023

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2024

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 5, 2024

Completed
Last Updated

August 5, 2024

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

January 15, 2024

Last Update Submit

July 31, 2024

Conditions

Keywords

Fear of childbirthguided imageryprimiparous pregnant womenpsychosocial health

Outcome Measures

Primary Outcomes (2)

  • Psychosocial Health Assessment Scale in Pregnancy

    Psychosocial Health Assessment Scale in Pregnancy. The minimum score that can be obtained from the scale is 46 and the maximum score is 230.

    12 weeks

  • Wijma Birth Expectation/ Experience Scale-A Version

    0 is expressed as "completely" and 5 is expressed as "none". While the minimum score on the scale is 0, the maximum score is 165.

    12 weeks

Secondary Outcomes (1)

  • Psychosocial Health Assessment Scale in Pregnancy sub-dimensions

    12 weeks

Study Arms (2)

Guided Imagery Practice

EXPERIMENTAL

Pregnant women in the experimental group were administered pre-tests (Personal Information Form, Psychosocial Health Assessment Scale in Pregnancy and Wijma Birth Expectancy/ Experience Scale - A Version) just before watching the guided imagery video. In the first interview with pregnant women, video viewing days and hours were determined by giving information about the guided imagery video. Pregnant women were then shown the guided imagery video consisting of a total of 12 weeks, once a day for 15 minutes and 50 seconds. Immediately after the 12-week period was completed, post-tests (Psychosocial Health Evaluation Scale in Pregnancy and Wijma Birth Expectancy/ Experience Scale - A Version) were administered to the pregnant women.

Behavioral: Guided Imagery Practice

group

NO INTERVENTION

Pregnant women in the control group were administered pre-tests (Personal Information Form, Psychosocial Health Assessment Scale in Pregnancy and Wijma Birth Expectancy/ Experience Scale) and post-tests (Psychosocial Health Assessment Scale in Pregnancy and Wijma Birth Expectancy/ Experience Scale - A Version) 12 weeks later and no practice was performed except routine practices during outpatient follow-up.

Interventions

Before the guided imagery application, the language translation of the guided imagery usage steps guide prepared by Owen (2010)27 was done by a translation center in a certified manner. Then, a relaxing, soothing, soft and slow-paced CD consisting of mixed nature sounds, photographs and music lasting 15 minutes and 50 seconds was prepared in the sound recording studio with the psychological counselor. Data collection forms were filled in by the researcher using face-to-face interview technique for the women who agreed to participate in the study. The guided imagery video was shared with the women and they were made to watch it once a day for 12 weeks in a quiet, calm, uncrowded, dimly lit room in their homes. The women in the control group did not receive any interventions other than routine interventions during outpatient follow-up.

Also known as: Guided Imagery
Guided Imagery Practice

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteer to participate in the study
  • Having no condition to prevent communication
  • Age 18-35
  • No vision and hearing problems
  • At the 24th-28th week of pregnancy
  • With a single fetus
  • Primiparous pregnancies

You may not qualify if:

  • Illiterate
  • Before the 24th week of pregnancy
  • Having multiple pregnancies
  • Multiparous
  • With psychopathological disease
  • Pregnant women with medical or pregnancy complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep Univeristy

Gaziantep, 0027, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Imagery, Psychotherapy

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

January 15, 2024

First Posted

August 5, 2024

Study Start

July 20, 2022

Primary Completion

January 20, 2023

Study Completion

January 1, 2024

Last Updated

August 5, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

THERE IS ONE AUTHOR.

Locations