- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06610513
Guided Imagery on Pregnancy Stress and Sleep Quality in Risky Pregnancy
September 20, 2024 updated by: Öznur Akçayüzlü, Cukurova University
Effect of Guided Imagery on Pregnancy Stress and Sleep Quality in Risky Pregnancy
In this thesis study, it is thought that with the guided imagery application to the hospitalized pregnant women, there will be a decrease in their stress levels and an increase in their sleep quality.
In our country, there is no study where guided imagery application is used in risky pregnant women.
It is thought that new information will be added to the literature as a result of this study.
This study will be conducted to determine the effect of guided imagery application on pregnancy stress and sleep quality in risky pregnant women.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
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
-
-
Sariçam
-
Adana, Sariçam, Turkey, 01330
- Adana City Training and Research Hospital
-
-
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
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Education level should be primary school or above
- Being in the 20th week of pregnancy or above
- Being planned to stay in the hospital for at least 5 days
- Being hospitalized for the first time during pregnancy
- Being within the first 3 days of hospitalization
- Knowing and speaking Turkish
- Being able to communicate verbally
Exclusion Criteria:
- Having had guided imagery before
- Having a diagnosis of mental illness
- Having become pregnant through infertility treatment
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: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Guided imagery group
Guided imagery will be applied to risky pregnant women in addition to normal nursing care.
|
First meeting: The women will be introduced to the clinic, the purpose of the study will be explained, and a written consent form will be filled out.
A Personal Information Form and the "Pregnancy Stress Assessment Scale" (GSDS-36) and the "Richard-Campbell Sleep Scale" will be filled out.
After the questionnaires are filled out, the vital signs of the pregnant woman will be measured and then a 15-minute guided imagery video will be shown.
The vital signs of the patient will be measured again 10 minutes after the guided imagery video is watched.
|
|
No Intervention: control group
Only routine nursing care will be provided to risky pregnant women.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pregnancy Stress Assessment Scale
Time Frame: During 5 days after the first meeting with participant
|
Pregnancy Stress Assessment Scale will be implemented to the pregnant women.
The degree of anxiety, distress and worry experienced by pregnant women is "definitely not", "mild", "moderate", "serious" or "very serious" and is given on a score ranging from 0 to 4, and the perceived stress levels during pregnancy range from a minimum of 0 to a maximum of 144 points.
As the score obtained from the scale increases, it is interpreted that stress increases.
|
During 5 days after the first meeting with participant
|
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, 2023
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
September 20, 2024
First Submitted That Met QC Criteria
September 20, 2024
First Posted (Actual)
September 24, 2024
Study Record Updates
Last Update Posted (Actual)
September 24, 2024
Last Update Submitted That Met QC Criteria
September 20, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 126
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
product manufactured in and exported from the U.S.
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.