- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05021289
Guided Imagery on the Perceived Stress Level in High-Risk Pregnancies
August 25, 2021 updated by: Nursel Alp Dal
Effect of the Practice of Guided Imagery on the Perceived Stress Level in High-Risk Pregnancies: Randomized Single-Blind Trial
This research was conducted to identify the effect of the practice of Guided Imagery on the perceived stress level in high-risk pregnancies.
Study Overview
Detailed Description
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).
Study Type
Interventional
Enrollment (Actual)
128
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Merkez
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Tunceli, Merkez, Turkey, 62002
- Munzur University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:• Having a high-risk pregnancy
- Being aged 18 years or above
- Agreeing to participate in the study
- Being literate in Turkish
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Guided İmagery
• participants were given one session of guided imagery.
|
guided imagery
|
No Intervention: control group
No intervention was applied on the control group patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived Stress Scale.
Time Frame: • 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.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2021
Primary Completion (Actual)
February 1, 2021
Study Completion (Actual)
May 1, 2021
Study Registration Dates
First Submitted
August 18, 2021
First Submitted That Met QC Criteria
August 23, 2021
First Posted (Actual)
August 25, 2021
Study Record Updates
Last Update Posted (Actual)
August 31, 2021
Last Update Submitted That Met QC Criteria
August 25, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- MunzurUn
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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