PregnancyNCT06924879
The Effects of the Mindfulness-Based Pregnancy Stress Reduction Program on Pregnant Women
A study testing Mindfulness-Based Pregnancy Stress Reduction Program in people with Pregnancy, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned as a randomized controlled experimental study to determine the effect of Mindfulness-Based Pregnancy Stress Reduction Program on stress levels, sleep quality and mindfulness levels of pregnant women. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Mindfulness-Based Pregnancy Stress Reduction Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- - Volunteering to participate in the research,
- Be over 18 years of age,
- Being literate,
- To be able to understand and speak Turkish,
- Nulliparous conception,
- Don't be a singleton,
- Gestational age between 24-32 weeks.
Who cannot join
- - Multiparous pregnancy,
- Don't have a high-risk pregnancy,
- Do not have a diagnosed psychiatric illness,
- Conception as a result of infertility treatment,
- Attending childbirth preparation courses
- Planning a cesarean birth
Show all 10Show fewer
- Previous experience of yoga and meditation,
- Don't want to leave the research,
- Not attending any session of the Mindfulness-Based Pregnancy Stress Reduction Program
- Failure to complete the data collection tools completely.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Vezirkopru County State Hospital
Samsun, 55000
About this study
Official title: The Effects of the Mindfulness -Based Pregnancy Stress Reduction Program on the Stress Levels, Sleep Quality and Awareness Levels of Pregnant Women
This study was planned as a randomized controlled experimental study to determine the effect of Mindfulness-Based Pregnancy Stress Reduction Program on stress levels, sleep quality and mindfulness levels of pregnant women.
Hypotheses of the Study:
Read more
Hypothesis 1 (H1): Mindfulness-Based Pregnancy Stress Reduction Program has an effect on reducing stress levels of pregnant women.
Hypothesis 2 (H1): Mindfulness-Based Pregnancy Stress Reduction Program has an effect on improving sleep quality of pregnant women.
Hypothesis 3 (H1): Mindfulness-Based Pregnancy Stress Reduction Program has an effect on increasing the mindfulness levels of pregnant women.
Hypothesis 4 (H1): Mindfulness-Based Pregnancy Stress Reduction Program has an effect on reducing women's stress levels in the postpartum period.
Hypothesis 5 (H1): Mindfulness-Based Pregnancy Stress Reduction Program has an effect on improving women's sleep quality in the postpartum period.
Hypothesis 6 (H1): Mindfulness-Based Pregnancy Stress Reduction Program has an effect on increasing women's mindfulness levels in the postpartum period.
It is planned to collect the research data from pregnant women who applied to the obstetrics and gynecology outpatient clinics of Vezirköprü State Hospital by face-to-face interview technique using Personal Information Form, Tilburg Distress in Pregnancy Scale, Pittsburgh Sleep Quality Index, Perceived Stress Scale and Mindfulness Scale.
It is planned to collect the research data in three stages. In the first stage, pre-test data will be collected from all pregnant women in the intervention and control groups who applied to the obstetrics outpatient clinic of Vezirköprü State Hospital, met the inclusion criteria and agreed to participate in the study. Pregnant women in the intervention group will be applied the Mindfulness-Based Pregnancy Stress Reduction Program consisting of 8 sessions and post-test data will be collected with measurement tools in the last trimester of pregnancy and 1-3 months after delivery. Pregnant women in the control group will not receive any intervention and will receive routine pregnancy care and practices. Post-test data will be collected from the pregnant women in the control group in the last trimester of pregnancy and between 1-3 months postpartum with measurement tools. After the post-test data are collected, the pregnant women in the control group will also receive mindfulness training.
Read the detailed description
This study was planned as a randomized controlled experimental study to determine the effect of Mindfulness-Based Pregnancy Stress Reduction Program on stress levels, sleep quality and mindfulness levels of pregnant women. This study have been conducted between June 01, 2024 and December 31, 2024 in the obstetrics outpatient clinics of Vezirköprü State Hospital affiliated to Samsun Provincial Health Directorate. There are two obstetrics outpatient clinics, breastfeeding counseling/lactation-relactation outpatient clinic and a pregnancy school in the hospital where the research will be conducted. In addition to the outpatient clinics, there are pregnancy monitoring and nonstress testing rooms.
The population of the study will consist of pregnant women who applied to the Obstetrics and Gynecology Outpatient Clinics of Vezirköprü District State Hospital affiliated to Samsun Provincial Health Directorate. Pregnant women who applied to Vezirköprü District State Hospital Obstetrics and Gynecology Outpatient Clinics and met the criteria for inclusion in the sample will be included in the sample of the study.
In order to determine a significant group effect in the sample calculation of the study, the minimum sample size was calculated as 33 pregnant women in the intervention group, 33 pregnant women in the control group, and 66 pregnant women in total, using an alpha margin of error of 0.05, a research power of 0.80 and an intermediate group effect (partial eta squared) of 0.03. In order to strengthen the results of the study and increase reliability and against the possibility of sample loss during the study, it was decided to include 80 pregnant women (40 intervention and 40 control), which is 20% more than the sample size.
It is planned to collect the research data from pregnant women who applied to the obstetrics and gynecology outpatient clinics of Vezirköprü State Hospital by face-to-face interview technique using Personal Information Form, Tilburg Distress in Pregnancy Scale, Pittsburgh Sleep Quality Index, Perceived Stress Scale and Mindfulness Scale.
It is planned to collect the research data in three stages. In the first stage, pre-test data will be collected from all pregnant women in the intervention and control groups who applied to the obstetrics outpatient clinic of Vezirköprü State Hospital, met the inclusion criteria and agreed to participate in the study. Pregnant women in the intervention group will be applied the Mindfulness-Based Pregnancy Stress Reduction Program consisting of 8 sessions and post-test data will be collected with measurement tools in the last trimester of pregnancy and 1-3 months after delivery. Pregnant women in the control group will not receive any intervention and will receive routine pregnancy care and practices. Post-test data will be collected from the pregnant women in the control group in the last trimester of pregnancy and between 1-3 months postpartum with measurement tools. After the post-test data are collected, the pregnant women in the control group will also receive mindfulness training.
- Conditions
- Pregnancy
- Being tested
- Mindfulness-Based Pregnancy Stress Reduction Program
- Keywords
- pregnancy, stress, sleep quality, nursing, mindfulness
- 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.
Mindfulness-Based Pregnancy Stress Reduction ProgramOther
Mindfulness-Based Pregnancy Stress Reduction Program Training Content Session 1 Introduction to the program Course preparation Orientation process Session 2 Introduction to Mindfulness practices Session 3 Focusing on the moment Session 4 Coping with thoughts Connecting with pregnant women's bodies Becoming aware of their thoughts, feelings and bodily senses Session 5 Releasing emotions and thoughts Session 6 Awareness Session 7 Keeping distance from thoughts Session 8 Accepting Awareness
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women participating in a mindfulness-based stress reduction program | Experimental | The Mindfulness-Based Pregnancy Stress Reduction Program consisting of 8 sessions will be applied to the pregnant women included in the intervention group and post-test data will be collected with measurement tools in the last trimester of pregnancy and 1-3 months after delivery after the training. Receives: Other: Mindfulness-Based Pregnancy Stress Reduction Program |
| Pregnant women not participating in a mindfulness-based stress reduction program | No intervention | Pregnant women in the control group will not receive any intervention and will receive routine pregnancy care and practices. Post-test data will be collected from the pregnant women in the control group in the last trimester of pregnancy and between 1-3 months after delivery with measurement tools. After the post-test data are collected, the pregnant women in the control group will also receive mindfulness training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tilburg Distress Scale in Pregnancy
The Tilburg Distress Scale in Pregnancy was developed to determine distress in pregnancy. The scale, which can be applied to pregnant women twelve weeks and over, consists of 16 items and is graded on a 4-point Likert scale (very often 0 points, quite often 1 point, occasionally 2 points, rarely/never 3 points). The total score that can be obtained from the scale varies between 0 and 48. According to the cut-off point, a total score of 28 and above indicates that the pregnant woman is at risk for distress. Items numbered 3, 5, 6, 7, 9, 10, 10, 11, 12, 13, 14, 16 in the scale are reverse coded. The scale has 2 sub-dimensions, "negative affect" consisting of 11 items and "partner involvement" consisting of 5 items. The items numbered 1, 2, 4, 8 and 15 in the scale belong to the "spousal involvement" sub-dimension, while the other items belong to the "negative affect" sub-dimension.
Measured: From participation until the end of the 8th week
Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index is a scale to assess sleep quality in psychiatry and clinical studies. The scale evaluates sleep disturbances and sleep quality in the last 1 month. The Turkish validity and reliability of the scale was performed by Agargün et al. Pittsburgh Sleep Quality Index consists of 24 questions and 7 sub-dimensions. These sub-dimensions are "subjective sleep quality", "sleep delay", "sleep duration", "habitual sleep efficiency", "sleep disturbance", "sleep medication use" and "daytime dysfunction". Each sub-dimension is evaluated with a score between 0-3 and the total scores of the sub-dimensions give the scale score. The total score of the scale is between 0-21. If the total score obtained from the scale is above 5, it is clinically evaluated as poor sleep quality (Agargün, 1996). Agargün et al. (1996) found the Cronbach's alpha reliability coefficient of the scale to be 0.804.
Measured: From participation until 1 to 3 months postpartum
Perceived Stress Scale
The Perceived Stress Scale was developed to determine the extent to which individuals perceive certain situations in their lives as stressful. Its Turkish validity and reliability was conducted by Eskin et al. The Perceived Stress Scale consists of 10 items and measures how stressful people perceive some situations in their lives. The scale is a five-point Likert scale and is scored as 0 "never", 1 "almost never", 2 "sometimes", 3 "often", 4 "very often". The scores of the items containing 7 positive statements in the scale are reversed and the total score of the scale is obtained by adding the scores of the other items. Scores between 0-56 can be obtained from the scale. There is no cut-off point in the scale, and an increase in the score indicates that the stress perception of the individual is high. Eskin et al. (2013) found the Cronbach's alpha internal consistency coefficient of the scale to be 0.84.
Measured: until the 1st to 3rd months after birth
Secondary outcomes (1)
Mindfulness Scale
The Mindfulness Scale (MBAS), developed to measures individual differences in attention and awareness skills towards momentary experiences (Brown \& Ryan, 2003).The Mindfulness Scale aims to determine whether there is awareness and attention in relation to what is happening in the present rather than elements related to mindfulness such as acceptance, trust, and co-sensation. It is used to assess individual differences in the frequency of mindfulness. It consists of 15 items, each with declarative and affirmative statements. The Mindfulness Scale measures how often individuals experience a particular situation using a 6-point Likert scale. Scores are between 1 and 6. The lowest score that can be obtained from the scale is 15 and the highest score is 90. A high score on the scale means that the level of mindfulness is high. Özyeşil et al. (2013) calculated the internal consistency coefficient of the scale as 0.82 and the test-retest correlation as 0.86.
Measured: From participation until 1 to 3 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start1 Jun 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
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.
- More trials run by Ondokuz Mayıs 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study consists of two groups: experimental and control group. In the study, while the control group will receive routine pregnancy care, the experimental group will receive an 8-session mindfulness-based pregnancy stress reduction program. Before randomization, pregnant women who meet the inclusion criteria will be informed about the study, their verbal and written consent will be obtained for participation in the study, and then pretest data will be collected. Personal Information Form, Tilburg Distress in Pregnancy Scale, Pittsburgh Sleep Quality Index and Mindfulness Scale will be used to collect pretest data from pregnant women who agree to participate in the study. After the pre-test data are collected, the pregnant women will be randomly assigned to one of the intervention and control groups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülendan Güntürk, Ondokuz Mayıs University
- Investigators
- Gülay Akman, PhD lecturer, Study director, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924879
- Sponsor's protocol ID
- 2024-363
- Status last verified
- Apr 2025
- First submitted
- 4 Apr 2025
- Last updated
- 16 Apr 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 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of the Mindfulness -Based Pregnancy Stress Reduction Program on the Stress Levels, Sleep Quality and Awareness Levels of Pregnant Women
- ClinicalTrials.gov ID
- NCT06924879
- Acronym / sponsor ID
- 2024-363
- Conditions
- Pregnancy
- Keywords
- pregnancy, stress, sleep quality, nursing, mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 11 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.
This study was planned as a randomized controlled experimental study to determine the effect of Mindfulness-Based Pregnancy Stress Reduction Program on stress levels, sleep quality and mindfulness levels of pregnant women.
Hypotheses of the Study:
Hypothesis 1 (H1): Mindfulness-Based Pregnancy Stress Reduction Program has an effect on reducing stress levels of pregnant women.
Hypothesis 2 (H1): Mindfulness-Based Pregnancy Stress Reduction Program has an effect on improving sleep quality of pregnant women.
Hypothesis 3 (H1): Mindfulness-Based Pregnancy Stress Reduction Program has an effect on increasing the mindfulness levels of pregnant women.
Hypothesis 4 (H1): Mindfulness-Based Pregnancy Stress Reduction Program has an effect on reducing women's stress levels in the postpartum period.
Hypothesis 5 (H1): Mindfulness-Based Pregnancy Stress Reduction Program has an effect on improving women's sleep quality in the postpartum period.
Hypothesis 6 (H1): Mindfulness-Based Pregnancy Stress Reduction Program has an effect on increasing women's mindfulness levels in the postpartum period.
It is planned to collect the research data from pregnant women who applied to the obstetrics and gynecology outpatient clinics of Vezirköprü State Hospital by face-to-face interview technique using Personal Information Form, Tilburg Distress in Pregnancy Scale, Pittsburgh Sleep Quality Index, Perceived Stress Scale and Mindfulness Scale.
It is planned to collect the research data in three stages. In the first stage, pre-test data will be collected from all pregnant women in the intervention and control groups who applied to the obstetrics outpatient clinic of Vezirköprü State Hospital, met the inclusion criteria and agreed to participate in the study. Pregnant women in the intervention group will be applied the Mindfulness-Based Pregnancy Stress Reduction Program consisting of 8 sessions and post-test data will be collected with measurement tools in the last trimester of pregnancy and 1-3 months after delivery. Pregnant women in the control group will not receive any intervention and will receive routine pregnancy care and practices. Post-test data will be collected from the pregnant women in the control group in the last trimester of pregnancy and between 1-3 months postpartum with measurement tools. After the post-test data are collected, the pregnant women in the control group will also receive mindfulness training.
Detailed description
This study was planned as a randomized controlled experimental study to determine the effect of Mindfulness-Based Pregnancy Stress Reduction Program on stress levels, sleep quality and mindfulness levels of pregnant women. This study have been conducted between June 01, 2024 and December 31, 2024 in the obstetrics outpatient clinics of Vezirköprü State Hospital affiliated to Samsun Provincial Health Directorate. There are two obstetrics outpatient clinics, breastfeeding counseling/lactation-relactation outpatient clinic and a pregnancy school in the hospital where the research will be conducted. In addition to the outpatient clinics, there are pregnancy monitoring and nonstress testing rooms.
The population of the study will consist of pregnant women who applied to the Obstetrics and Gynecology Outpatient Clinics of Vezirköprü District State Hospital affiliated to Samsun Provincial Health Directorate. Pregnant women who applied to Vezirköprü District State Hospital Obstetrics and Gynecology Outpatient Clinics and met the criteria for inclusion in the sample will be included in the sample of the study.
In order to determine a significant group effect in the sample calculation of the study, the minimum sample size was calculated as 33 pregnant women in the intervention group, 33 pregnant women in the control group, and 66 pregnant women in total, using an alpha margin of error of 0.05, a research power of 0.80 and an intermediate group effect (partial eta squared) of 0.03. In order to strengthen the results of the study and increase reliability and against the possibility of sample loss during the study, it was decided to include 80 pregnant women (40 intervention and 40 control), which is 20% more than the sample size.
It is planned to collect the research data from pregnant women who applied to the obstetrics and gynecology outpatient clinics of Vezirköprü State Hospital by face-to-face interview technique using Personal Information Form, Tilburg Distress in Pregnancy Scale, Pittsburgh Sleep Quality Index, Perceived Stress Scale and Mindfulness Scale.
It is planned to collect the research data in three stages. In the first stage, pre-test data will be collected from all pregnant women in the intervention and control groups who applied to the obstetrics outpatient clinic of Vezirköprü State Hospital, met the inclusion criteria and agreed to participate in the study. Pregnant women in the intervention group will be applied the Mindfulness-Based Pregnancy Stress Reduction Program consisting of 8 sessions and post-test data will be collected with measurement tools in the last trimester of pregnancy and 1-3 months after delivery. Pregnant women in the control group will not receive any intervention and will receive routine pregnancy care and practices. Post-test data will be collected from the pregnant women in the control group in the last trimester of pregnancy and between 1-3 months postpartum with measurement tools. After the post-test data are collected, the pregnant women in the control group will also receive mindfulness training.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The study consists of two groups: experimental and control group. In the study, while the control group will receive routine pregnancy care, the experimental group will receive an 8-session mindfulness-based pregnancy stress reduction program. Before randomization, pregnant women who meet the inclusion criteria will be informed about the study, their verbal and written consent will be obtained for participation in the study, and then pretest data will be collected. Personal Information Form, Tilburg Distress in Pregnancy Scale, Pittsburgh Sleep Quality Index and Mindfulness Scale will be used to collect pretest data from pregnant women who agree to participate in the study. After the pre-test data are collected, the pregnant women will be randomly assigned to one of the intervention and control groups.
| Arm | Type | Receives |
|---|---|---|
| Pregnant women participating in a mindfulness-based stress reduction program | Experimental | Other: Mindfulness-Based Pregnancy Stress Reduction ProgramThe Mindfulness-Based Pregnancy Stress Reduction Program consisting of 8 sessions will be applied to the pregnant women included in the intervention group and post-test data will be collected with measurement tools in the last trimester of pregnancy and 1-3 months after delivery after the training. |
| Pregnant women not participating in a mindfulness-based stress reduction program | No intervention | –Pregnant women in the control group will not receive any intervention and will receive routine pregnancy care and practices. Post-test data will be collected from the pregnant women in the control group in the last trimester of pregnancy and between 1-3 months after delivery with measurement tools. After the post-test data are collected, the pregnant women in the control group will also receive mindfulness training. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- - Volunteering to participate in the research,
- Be over 18 years of age,
- Being literate,
- To be able to understand and speak Turkish,
- Nulliparous conception,
Key exclusion criteria (10 listed)
- - Multiparous pregnancy,
- Don't have a high-risk pregnancy,
- Do not have a diagnosed psychiatric illness,
- Conception as a result of infertility treatment,
- Attending childbirth preparation courses
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 |
|---|---|---|
| Mindfulness-Based Pregnancy Stress Reduction ProgramMindfulness-Based Pregnancy Stress Reduction Program Training Content Session 1 Introduction to the program Course preparation Orientation process Session 2 Introduction to Mindfulness practices Session 3 Focusing on the moment Session 4 Coping with thoughts Connecting with pregnant women's bodies Becoming aware of their thoughts, feelings and bodily senses Session 5 Releasing emotions and thoughts Session 6 Awareness Session 7 Keeping distance from thoughts Session 8 Accepting Awareness | Other | Pregnant women participating in a mindfulness-based stress reduction program |
Primary outcome
Tilburg Distress Scale in Pregnancy
Time frame: From participation until the end of the 8th week
The Tilburg Distress Scale in Pregnancy was developed to determine distress in pregnancy. The scale, which can be applied to pregnant women twelve weeks and over, consists of 16 items and is graded on a 4-point Likert scale (very often 0 points, quite often 1 point, occasionally 2 points, rarely/never 3 points). The total score that can be obtained from the scale varies between 0 and 48. According to the cut-off point, a total score of 28 and above indicates that the pregnant woman is at risk for distress. Items numbered 3, 5, 6, 7, 9, 10, 10, 11, 12, 13, 14, 16 in the scale are reverse coded. The scale has 2 sub-dimensions, "negative affect" consisting of 11 items and "partner involvement" consisting of 5 items. The items numbered 1, 2, 4, 8 and 15 in the scale belong to the "spousal involvement" sub-dimension, while the other items belong to the "negative affect" sub-dimension.
Pittsburgh Sleep Quality Index
Time frame: From participation until 1 to 3 months postpartum
Pittsburgh Sleep Quality Index is a scale to assess sleep quality in psychiatry and clinical studies. The scale evaluates sleep disturbances and sleep quality in the last 1 month. The Turkish validity and reliability of the scale was performed by Agargün et al. Pittsburgh Sleep Quality Index consists of 24 questions and 7 sub-dimensions. These sub-dimensions are "subjective sleep quality", "sleep delay", "sleep duration", "habitual sleep efficiency", "sleep disturbance", "sleep medication use" and "daytime dysfunction". Each sub-dimension is evaluated with a score between 0-3 and the total scores of the sub-dimensions give the scale score. The total score of the scale is between 0-21. If the total score obtained from the scale is above 5, it is clinically evaluated as poor sleep quality (Agargün, 1996). Agargün et al. (1996) found the Cronbach's alpha reliability coefficient of the scale to be 0.804.
Perceived Stress Scale
Time frame: until the 1st to 3rd months after birth
The Perceived Stress Scale was developed to determine the extent to which individuals perceive certain situations in their lives as stressful. Its Turkish validity and reliability was conducted by Eskin et al. The Perceived Stress Scale consists of 10 items and measures how stressful people perceive some situations in their lives. The scale is a five-point Likert scale and is scored as 0 "never", 1 "almost never", 2 "sometimes", 3 "often", 4 "very often". The scores of the items containing 7 positive statements in the scale are reversed and the total score of the scale is obtained by adding the scores of the other items. Scores between 0-56 can be obtained from the scale. There is no cut-off point in the scale, and an increase in the score indicates that the stress perception of the individual is high. Eskin et al. (2013) found the Cronbach's alpha internal consistency coefficient of the scale to be 0.84.
1 secondary outcome
Mindfulness Scale
Time frame: From participation until 1 to 3 months postpartum
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 16 Apr 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.
Gülay Akman, PhD lecturer study director
Ondokuz Mayıs University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Pregnancy Stress Reduction Program in people with Pregnancy, run by Ondokuz Mayıs 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 10 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 16 Apr 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?
Tilburg Distress Scale in Pregnancy (time frame: From participation until the end of the 8th week). 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 16 Apr 2025; AzTrials last refreshed its copy on 6 Nov 2026.