NCT05021289

Brief Summary

This research was conducted to identify the effect of the practice of Guided Imagery on the perceived stress level in high-risk pregnancies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

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

February 1, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 25, 2021

Completed
Last Updated

August 31, 2021

Status Verified

August 1, 2021

Enrollment Period

Same day

First QC Date

August 18, 2021

Last Update Submit

August 25, 2021

Conditions

Keywords

Guided ImageryPerceived Stress LevelHigh-Risk Pregnancies.

Outcome Measures

Primary Outcomes (1)

  • Perceived Stress Scale.

    Evaluation of the stress level of pregnant women with the Perceived Stress Scale. Comprised of 14 items in total, the scale was designed to measure the extent to which circumstances in one's life are perceived as stressful. The respondents evaluate the items based on a five-point Likert scale that is scored from '0: Never' to '4: Very Often'. Seven positively-stated items are reverse scored. The minimum and maximum scores to be obtained from the scale are successively 0 and 56 points. A high score obtained from the scale indicates that the respondent has high-level stress perception.

    • The first practice of guided imagery was performed face-to-face with pregnant women. At the end of 20 minutes, the pregnant women's stress levels were reevaluated by using the Perceived Stress Scale.

Study Arms (2)

Guided İmagery

EXPERIMENTAL

• participants were given one session of guided imagery.

Behavioral: guided imagery

control group

NO INTERVENTION

No intervention was applied on the control group patients.

Interventions

guided imageryBEHAVIORAL

guided imagery

Guided İmagery

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe research population was comprised of all women who had high-risk pregnancies and received treatment at the perinatology service of the aforementioned hospital in the above period
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being aged 18 years or above
  • Agreeing to participate in the study
  • Being literate in Turkish

You may not qualify if:

  • The pregnant women who voluntarily wanted to leave the research at any stage after being included in the study, could not communicate verbally, had a visual or hearing disorder, and were previously diagnosed with a psychiatric disease were excluded from the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Munzur University

Tunceli, Merkez, 62002, 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
Masking Details
care provider
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: Designed as a prospective randomized single-blind trial, the research was performed with the participation of a total of 128 women who had high-risk pregnancies and received inpatient treatment on 1 February - 1 May 2021 at the perinatology service of a maternity and children's hospital located in the Anatolian side of Istanbul province of Turkey (64 pregnant women in the experimental group, 64 pregnant women in the control group).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 18, 2021

First Posted

August 25, 2021

Study Start

February 1, 2021

Primary Completion

February 1, 2021

Study Completion

May 1, 2021

Last Updated

August 31, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations