High Risk PregnancyNCT05021289
Guided Imagery on the Perceived Stress Level in High-Risk Pregnancies
A study testing guided imagery in people with High Risk Pregnancy, run by Nursel Alp Dal at 1 site in Turkey (Türkiye).
Trial summary
This research was conducted to identify the effect of the practice of Guided Imagery on the perceived stress level in high-risk pregnancies. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- High Risk Pregnancy
- 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
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 1 May 2021
- 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 aged 18 years or above
- Agreeing to participate in the study
- Being literate in Turkish
Who cannot join
- The pregnant women who voluntarily wanted to leave the research at any stage after being included in the study, could not communicate verbally, had a visual or hearing disorder, and were previously diagnosed with a psychiatric disease were excluded from the research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Practice of Guided Imagery on the Perceived Stress Level in High-Risk Pregnancies: Randomized Single-Blind Trial
This research was conducted to identify the effect of the practice of Guided Imagery on the perceived stress level in high-risk pregnancies.
Read the detailed description
Designed as a prospective randomized single-blind trial, the research was performed with the participation of a total of 128 women who had high-risk pregnancies and received inpatient treatment on 1 February - 1 May 2021 at the perinatology service of a maternity and children's hospital located in the Anatolian side of Istanbul province of Turkey (64 pregnant women in the experimental group, 64 pregnant women in the control group).
- Conditions
- High Risk Pregnancy
- Being tested
- guided imagery
- Keywords
- Guided Imagery, Perceived Stress Level, High-Risk Pregnancies.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
guided imageryBehavioural
guided imagery
| Study group | Role | What they receive |
|---|---|---|
| Guided İmagery | Experimental | • participants were given one session of guided imagery. Receives: Behavioral: guided imagery |
| control group | No intervention | No intervention was applied on the control group patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale.
Evaluation of the stress level of pregnant women with the Perceived Stress Scale. Comprised of 14 items in total, the scale was designed to measure the extent to which circumstances in one's life are perceived as stressful. The respondents evaluate the items based on a five-point Likert scale that is scored from '0: Never' to '4: Very Often'. Seven positively-stated items are reverse scored. The minimum and maximum scores to be obtained from the scale are successively 0 and 56 points. A high score obtained from the scale indicates that the respondent has high-level stress perception.
Measured: • The first practice of guided imagery was performed face-to-face with pregnant women. At the end of 20 minutes, the pregnant women's stress levels were reevaluated by using the Perceived Stress Scale.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start1 Feb 2021
- Primary completion1 Feb 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk 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
- Crossover
- Model description
- Designed as a prospective randomized single-blind trial, the research was performed with the participation of a total of 128 women who had high-risk pregnancies and received inpatient treatment on 1 February - 1 May 2021 at the perinatology service of a maternity and children's hospital located in the Anatolian side of Istanbul province of Turkey (64 pregnant women in the experimental group, 64 pregnant women in the control group).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nursel Alp Dal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nursel Alp Dal, Munzur University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021289
- Sponsor's protocol ID
- MunzurUn
- Status last verified
- Aug 2021
- First submitted
- 18 Aug 2021
- Last updated
- 31 Aug 2021
- 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 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Practice of Guided Imagery on the Perceived Stress Level in High-Risk Pregnancies: Randomized Single-Blind Trial
- ClinicalTrials.gov ID
- NCT05021289
- Acronym / sponsor ID
- MunzurUn
- Conditions
- High Risk Pregnancy
- Keywords
- Guided Imagery, Perceived Stress Level, High-Risk Pregnancies.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Nursel Alp DalUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 25 Aug 2021 (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.
This research was conducted to identify the effect of the practice of Guided Imagery on the perceived stress level in high-risk pregnancies.
Detailed description
Designed as a prospective randomized single-blind trial, the research was performed with the participation of a total of 128 women who had high-risk pregnancies and received inpatient treatment on 1 February - 1 May 2021 at the perinatology service of a maternity and children's hospital located in the Anatolian side of Istanbul province of Turkey (64 pregnant women in the experimental group, 64 pregnant women in the control group).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Designed as a prospective randomized single-blind trial, the research was performed with the participation of a total of 128 women who had high-risk pregnancies and received inpatient treatment on 1 February - 1 May 2021 at the perinatology service of a maternity and children's hospital located in the Anatolian side of Istanbul province of Turkey (64 pregnant women in the experimental group, 64 pregnant women in the control group).
| Arm | Type | Receives |
|---|---|---|
| Guided İmagery | Experimental | Behavioral: guided imagery• participants were given one session of guided imagery. |
| control group | No intervention | –No intervention was applied on the control group patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being aged 18 years or above
- Agreeing to participate in the study
- Being literate in Turkish
Key exclusion criteria (1 listed)
- The pregnant women who voluntarily wanted to leave the research at any stage after being included in the study, could not communicate verbally, had a visual or hearing disorder, and were previously diagnosed with a psychiatric disease were excluded from the research
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 imageryguided imagery | Behavioural | Guided İmagery |
Primary outcome
Perceived Stress Scale.
Time frame: • The first practice of guided imagery was performed face-to-face with pregnant women. At the end of 20 minutes, the pregnant women's stress levels were reevaluated by using the Perceived Stress Scale.
Evaluation of the stress level of pregnant women with the Perceived Stress Scale. Comprised of 14 items in total, the scale was designed to measure the extent to which circumstances in one's life are perceived as stressful. The respondents evaluate the items based on a five-point Likert scale that is scored from '0: Never' to '4: Very Often'. Seven positively-stated items are reverse scored. The minimum and maximum scores to be obtained from the scale are successively 0 and 56 points. A high score obtained from the scale indicates that the respondent has high-level stress perception.
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 31 Aug 2021.
- 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.
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 High Risk Pregnancy, run by Nursel Alp Dal 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 3 inclusion and 1 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 31 Aug 2021. 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?
Perceived Stress Scale. (time frame: • The first practice of guided imagery was performed face-to-face with pregnant women. At the end of 20 minutes, the pregnant women's stress levels were reevaluated by using the Perceived Stress Scale.). 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 31 Aug 2021.