PregnancyNCT06949514
Guided Imagery in Hospitalized Pregnant Women
A study testing guided imagery in people with Pregnancy, run by Menekşe Nazlı AKER at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- guided imagery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Apr 2025to 28 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Guided Imagery on Anxiety, Depression, and Sleep in Hospitalized Pregnant Women
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.
- Conditions
- Pregnancy
- Being tested
- guided imagery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Guided imagery group Receives: Other: guided imagery |
| Control Group | No intervention | Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: at the beginning of the study, 3 days later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start28 Apr 2025
- Primary completion28 Jul 2025
- Study completion28 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menekşe Nazlı AKER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Menekşe Nazlı AKER, Ankara University
- Investigators
- Menekşe Nazlı Aker, Study director, Assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06949514
- Sponsor's protocol ID
- 06.01.2025/01-14
- Status last verified
- Aug 2025
- First submitted
- 22 Apr 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Guided Imagery on Anxiety, Depression, and Sleep in Hospitalized Pregnant Women
- ClinicalTrials.gov ID
- NCT06949514
- Acronym / sponsor ID
- 06.01.2025/01-14
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Menekşe Nazlı AKERUniversity, hospital or other
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 28 Jul 2025 (actual)
- Study completion
- 28 Jul 2025 (actual)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: guided imageryGuided imagery group |
| Control Group | No intervention | –Control Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| guided imageryParticipants 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. | Other | Intervention Group |
Primary outcome
Change in anxiety
Time frame: at the beginning of the study, 3 days later
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.
Change in Depression
Time frame: at the beginning of the study, 3 days later
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.
Change in Sleep Quality
Time frame: at the beginning of the study, 3 days later
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Menekşe Nazlı Aker study director
Assistant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing guided imagery in people with Pregnancy, run by Menekşe Nazlı AKER at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anxiety (time frame: at the beginning of the study, 3 days later). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.