Effect of Guided Imagery Application on Pregnancy Stress and Sleep Quality in Risky Pregnant Women Will Be CheckedNCT06610513
Guided Imagery on Pregnancy Stress and Sleep Quality in Risky Pregnancy
A study testing Guided imagery in people with Effect of Guided Imagery Application on Pregnancy Stress and Sleep Quality in Risky Pregnant Women Will Be Checked, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Effect of Guided Imagery Application on Pregnancy Stress and Sleep Quality in Risky Pregnant Women Will Be Checked
- What is being tested?
- Guided imagery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2023to 31 Dec 2024
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Having had guided imagery before
- Having a diagnosis of mental illness
- Having become pregnant through infertility treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adana City Training and Research Hospital
Adana, Sariçam, 01330
About this study
Official title: 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.
- Being tested
- Guided imagery
- Keywords
- Guided imagery, pregnancy, stress, sleep quality, risky pregnancy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided imageryBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Guided imagery group | Experimental | Guided imagery will be applied to risky pregnant women in addition to normal nursing care. Receives: Behavioral: Guided imagery |
| control group | No intervention | Only routine nursing care will be provided to risky pregnant women. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During 5 days after the first meeting with participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start1 Feb 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Guided Imagery Application on Pregnancy Stress and Sleep Quality in Risky Pregnant Women Will Be CheckedStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Öznur Akçayüzlü, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610513
- Sponsor's protocol ID
- 126
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2024
- Last updated
- 24 Sep 2024
- 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 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Guided Imagery on Pregnancy Stress and Sleep Quality in Risky Pregnancy
- ClinicalTrials.gov ID
- NCT06610513
- Acronym / sponsor ID
- 126
- Keywords
- Guided imagery, pregnancy, stress, sleep quality, risky pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 24 Sep 2024 (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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided imagery group | Experimental | Behavioral: Guided imageryGuided imagery will be applied to risky pregnant women in addition to normal nursing care. |
| control group | No intervention | –Only routine nursing care will be provided to risky pregnant women. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Having had guided imagery before
- Having a diagnosis of mental illness
- Having become pregnant through infertility treatment
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 imageryFirst 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. | Behavioural | Guided imagery group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Effect of Guided Imagery Application on Pregnancy Stress and Sleep Quality in Risky Pregnant Women Will Be Checked, run by Cukurova University 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 3 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: status not confirmed, as of the sponsor's last update on 24 Sep 2024. 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?
Results are not available in the source record.
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?
Pregnancy Stress Assessment Scale (time frame: During 5 days after the first meeting with participant). 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 24 Sep 2024.