NCT06610513

Brief Summary

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.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 24, 2024

Status Verified

September 1, 2024

Enrollment Period

1.8 years

First QC Date

September 20, 2024

Last Update Submit

September 20, 2024

Conditions

Keywords

Guided imagerypregnancystresssleep qualityrisky pregnancy

Outcome Measures

Primary Outcomes (1)

  • Pregnancy Stress Assessment Scale

    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

Study Arms (2)

Guided imagery group

EXPERIMENTAL

Guided imagery will be applied to risky pregnant women in addition to normal nursing care.

Behavioral: Guided imagery

control group

NO INTERVENTION

Only routine nursing care will be provided to risky pregnant women.

Interventions

Guided imageryBEHAVIORAL

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.

Guided imagery group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen who have risky pregnancy will be included, therefore the study is gender based.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Having had guided imagery before
  • Having a diagnosis of mental illness
  • Having become pregnant through infertility treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adana City Training and Research Hospital

Adana, Sariçam, 01330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Imagery, Psychotherapy

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to the study\'s nature, masking could not be performed.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MsC, RN

Study Record Dates

First Submitted

September 20, 2024

First Posted

September 24, 2024

Study Start

February 1, 2023

Primary Completion

December 1, 2024

Study Completion

December 31, 2024

Last Updated

September 24, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations