NCT06949514

Brief Summary

The study will be carried out in two different groups. Participants will be approached after being hospitalized for at least 24 hours. After the pregnant women are evaluated in terms of eligibility criteria for the research, the pregnant women who are eligible will be informed about the research and written informed consent will be obtained from the pregnant women who accept. The random distribution of pregnant women to the study groups will be carried out random.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at below P25 for not_applicable pregnancy

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable pregnancy

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

First Submitted

Initial submission to the registry

April 22, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

April 28, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 29, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2025

Completed
Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

April 22, 2025

Last Update Submit

August 25, 2025

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (3)

  • Change in anxiety

    The Hospital Anxiety and Depression Scale is a four-point Likert-type scale used to determine the risk, level, and change in severity of anxiety and depression in patients. The scale consists of 14 items; odd-numbered items assess anxiety, and even-numbered items assess depression. For the anxiety subscale, the cut-off score is 10/11. Individuals scoring above this threshold are considered to be at risk. The lowest possible score on the scale is 0, and the highest possible score is 21.

    at the beginning of the study, 3 days later

  • Change in Depression

    The Hospital Anxiety and Depression Scale is a four-point Likert-type scale used to determine the risk, level, and change in severity of anxiety and depression in patients. The scale consists of 14 items; odd-numbered items assess anxiety, and even-numbered items assess depression. For the depression subscale, the cut-off score is 7/8. Individuals scoring above this threshold are considered to be at risk. The lowest possible score on the scale is 0, and the highest possible score is 21.

    at the beginning of the study, 3 days later

  • Change in Sleep Quality

    The Richard-Campbell Sleep Questionnaire consists of six items that evaluate the depth of night sleep, time taken to fall asleep, frequency of awakenings, duration of wakefulness upon awakening, overall sleep quality, and the level of noise in the environment. Each item is assessed using a visual analog scale ranging from 0 to 100. Scores between 0-25 indicate very poor sleep, while scores between 76-100 indicate very good sleep. As the total score increases, the sleep quality of patients also improves.

    at the beginning of the study, 3 days later

Study Arms (2)

Intervention Group

EXPERIMENTAL

Guided imagery group

Other: guided imagery

Control Group

NO INTERVENTION

Control Group

Interventions

guided imageryOTHER

Participants in this group will receive the guided imagery intervention. They will be approached after being hospitalized for at least 24 hours. The guided imagery audio recording will be played for the pregnant women every evening before sleep for three consecutive days.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being 18 years of age or older
  • Having no difficulties in understanding and speaking Turkish
  • Being hospitalized for at least 24 hours
  • Being in the second trimester of pregnancy (14-28 weeks)
  • Having a medically stable condition
  • Experiencing sleep disturbances
  • Voluntarily agreeing to take part in the study

You may not qualify if:

  • Having a hearing impairment
  • Having ongoing severe vaginal bleeding
  • Having a diagnosed psychiatric disorder and/or using psychiatric medication
  • Having uncontrolled hypertension
  • Presence of intrauterine fetal demise
  • Premature rupture of membranes (PROM)
  • Being in preterm labor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aksaray Eğitim Araştırma Hastanesi

Aksaray, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Imagery, Psychotherapy

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Menekşe Nazlı Aker

    Assistant professor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

April 22, 2025

First Posted

April 29, 2025

Study Start

April 28, 2025

Primary Completion

July 28, 2025

Study Completion

July 28, 2025

Last Updated

August 29, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)