Pregnancy RelatedNCT06316518
The Effect of Mindfulness-Based Web-Based Stress Reduction Program Applied to Primigravidas on Perceived Stress Level in Pregnancy, Birth Self-Efficacy and Prenatal Attachment
A study testing mindfulness group in people with Pregnancy Related, run by Ataturk University.
Trial summary
The aim of this study is to investigate the effect of a mindfulness-based web-based stress reduction program applied to primigravidas on perceived stress level in pregnancy, birth self-efficacy and prenatal attachment. 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 Related
- What is being tested?
- mindfulness group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 1 May 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 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Graduated from at least primary school
- Having a computer or a cell phone,
- Having access to the Internet,
- Being between the ages of 18-35,
- Being 18-24 weeks pregnant,
- Having a single healthy fetus,
Show all 10Show fewer
- Being primigravida,
- Not having a risky pregnancy (such as placenta previa, preeclampsia, not having any systemic disease),
- Not participating in any childbirth preparation class
- Not having a neurological or psychiatric disease.
Who cannot join
- Voluntary withdrawal from the study
- Failure to complete the 8-module training for any reason
- Interruption of internet access and inability to communicate
- Termination of pregnancy for any reason
- Non-participation in the trainings given in the experimental group
About this study
The aim of this study is to investigate the effect of a mindfulness-based web-based stress reduction program applied to primigravidas on perceived stress level in pregnancy, birth self-efficacy and prenatal attachment.
Read the detailed description
Pregnancy is a process in which physical and hormonal changes occur in the female body. During this period, women experience mood swings due to changes in hormonal and social roles. These changes may predispose some women to mental health problems. Due to physiological and psychological changes during pregnancy, pregnant women may experience some problems such as nausea, vomiting, fatigue, anxiety, stress and depression . It is important to show pregnant women that these are normal experiences and to adopt an accepting attitude towards these experiences.
Perceived stress during pregnancy can cause many negative effects on maternal and fetal health. Among the causes of perceived stress are being diagnosed with a risky pregnancy, the presence of danger symptoms during pregnancy, the occurrence of adverse conditions during pregnancy and uncertainties about the pregnancy process.
Birth self-efficacy is defined as the level of assurance that a mother can give birth by using her abilities successfully. Birth self-efficacy is a motivating factor for the mother to cope with childbirth. High self-efficacy can reduce fear of childbirth and lead to better birth outcomes.
Prenatal attachment is defined as the expectant mother's attachment to the fetus through her behavior during pregnancy, establishing a close relationship and interacting with it. Prenatal attachment is an important component of the concept of fetal protection with the mother's attitudes of recognizing, being with and protecting her baby. The bond between mother and fetus has a great impact on the social and emotional development of the baby. A significant part of the attachment between mother and fetus begins during pregnancy and increases within a month after birth.
Supportive interventions, when necessary, to reduce perceived stress in pregnant women are critical for the protection of women's overall health. One of the non-pharmacological interventions is a mindfulness-based stress reduction program. Due to the success of standardized mindfulness-based interventions, mindfulness-based interventions have rapidly spread in western psychology research and practice. Abdolalipour et al. In a systematic review and meta-analysis of ten studies in 2023, Abdolalipour et al. reported that mindfulness practice reduced fear of childbirth.
- Conditions
- Pregnancy Related
- Being tested
- mindfulness group
- Keywords
- Self Efficacy, Mindfulness, pregnancy, Stress,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness groupOther
In the study, primigravidas will receive 8-module (8-week-long) trainings, each lasting approximately 45 minutes, 3 days a week.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness group | Experimental | Primigravidas randomly assigned to the experimental group will be given web-based mindfulness-based stress reduction trainings after pre-tests are applied. Receives: Other: mindfulness group |
| control group | Active comparator | After the pre-tests were applied to the control group, routine nursing care will be given and post-test measurements will be made after 8 weeks. Receives: Other: mindfulness group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy Stress Assessment Scale (PSAS)
The initial scale consisting of 40 items was revised as 36 items as a result of the validity and reliability study conducted in Taiwan. The scale consists of seven (7) sub-dimensions and is 5-point Likert type. Each item is evaluated as (absolutely no (0), mild (1), moderate (2), severe (3), very severe (4)). The lowest score that can be obtained from the scale is 0 and the highest score is 144.
Measured: Two months
Self-Efficacy Scale for Normal Childbirth
There are 9 items in the scale. For each item in the scale, scores from 0 to 10 are given and scored as 0 points = no confidence at all and 10 points = very confident. The lowest score that can be obtained from the Self-Efficacy Scale for Normal Birth is 0, while the highest score that can be obtained is 90. As the scores obtained from the self-efficacy scale increase, the degree of self-efficacy also increases.
Measured: Two months
Prenatal Attachment Inventory (PAI)
The inventory consists of 21 items and is four-point Likert type. The items of the inventory are scored between 1 and 4 points as 1-Never, 2-Sometimes, 3-Frequently, 4-Always. A minimum of 21 and a maximum of 84 points can be obtained from the inventory. An increase in the score obtained from the inventory indicates an increase in the level of attachment.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies 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
- Model description
- Two groups with a supportive care control groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YILMAZ, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316518
- Sponsor's protocol ID
- AIBU-HF-YS-01
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness-Based Web-Based Stress Reduction Program Applied to Primigravidas on Perceived Stress Level in Pregnancy, Birth Self-Efficacy and Prenatal Attachment
- ClinicalTrials.gov ID
- NCT06316518
- Acronym / sponsor ID
- AIBU-HF-YS-01
- Conditions
- Pregnancy Related
- Keywords
- Self Efficacy, Mindfulness, pregnancy, Stress,
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 18 Mar 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.
The aim of this study is to investigate the effect of a mindfulness-based web-based stress reduction program applied to primigravidas on perceived stress level in pregnancy, birth self-efficacy and prenatal attachment.
Detailed description
Pregnancy is a process in which physical and hormonal changes occur in the female body. During this period, women experience mood swings due to changes in hormonal and social roles. These changes may predispose some women to mental health problems. Due to physiological and psychological changes during pregnancy, pregnant women may experience some problems such as nausea, vomiting, fatigue, anxiety, stress and depression . It is important to show pregnant women that these are normal experiences and to adopt an accepting attitude towards these experiences.
Perceived stress during pregnancy can cause many negative effects on maternal and fetal health. Among the causes of perceived stress are being diagnosed with a risky pregnancy, the presence of danger symptoms during pregnancy, the occurrence of adverse conditions during pregnancy and uncertainties about the pregnancy process.
Birth self-efficacy is defined as the level of assurance that a mother can give birth by using her abilities successfully. Birth self-efficacy is a motivating factor for the mother to cope with childbirth. High self-efficacy can reduce fear of childbirth and lead to better birth outcomes.
Prenatal attachment is defined as the expectant mother's attachment to the fetus through her behavior during pregnancy, establishing a close relationship and interacting with it. Prenatal attachment is an important component of the concept of fetal protection with the mother's attitudes of recognizing, being with and protecting her baby. The bond between mother and fetus has a great impact on the social and emotional development of the baby. A significant part of the attachment between mother and fetus begins during pregnancy and increases within a month after birth.
Supportive interventions, when necessary, to reduce perceived stress in pregnant women are critical for the protection of women's overall health. One of the non-pharmacological interventions is a mindfulness-based stress reduction program. Due to the success of standardized mindfulness-based interventions, mindfulness-based interventions have rapidly spread in western psychology research and practice. Abdolalipour et al. In a systematic review and meta-analysis of ten studies in 2023, Abdolalipour et al. reported that mindfulness practice reduced fear of childbirth.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two groups with a supportive care control groups
| Arm | Type | Receives |
|---|---|---|
| Mindfulness group | Experimental | Other: mindfulness groupPrimigravidas randomly assigned to the experimental group will be given web-based mindfulness-based stress reduction trainings after pre-tests are applied. |
| control group | Active comparator | Other: mindfulness groupAfter the pre-tests were applied to the control group, routine nursing care will be given and post-test measurements will be made after 8 weeks. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Graduated from at least primary school
- Having a computer or a cell phone,
- Having access to the Internet,
- Being between the ages of 18-35,
- Being 18-24 weeks pregnant,
Key exclusion criteria (5 listed)
- Voluntary withdrawal from the study
- Failure to complete the 8-module training for any reason
- Interruption of internet access and inability to communicate
- Termination of pregnancy for any reason
- Non-participation in the trainings given in the experimental group
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 groupIn the study, primigravidas will receive 8-module (8-week-long) trainings, each lasting approximately 45 minutes, 3 days a week. | Other | Mindfulness group, control group |
Primary outcome
Pregnancy Stress Assessment Scale (PSAS)
Time frame: Two months
The initial scale consisting of 40 items was revised as 36 items as a result of the validity and reliability study conducted in Taiwan. The scale consists of seven (7) sub-dimensions and is 5-point Likert type. Each item is evaluated as (absolutely no (0), mild (1), moderate (2), severe (3), very severe (4)). The lowest score that can be obtained from the scale is 0 and the highest score is 144.
Self-Efficacy Scale for Normal Childbirth
Time frame: Two months
There are 9 items in the scale. For each item in the scale, scores from 0 to 10 are given and scored as 0 points = no confidence at all and 10 points = very confident. The lowest score that can be obtained from the Self-Efficacy Scale for Normal Birth is 0, while the highest score that can be obtained is 90. As the scores obtained from the self-efficacy scale increase, the degree of self-efficacy also increases.
Prenatal Attachment Inventory (PAI)
Time frame: Two months
The inventory consists of 21 items and is four-point Likert type. The items of the inventory are scored between 1 and 4 points as 1-Never, 2-Sometimes, 3-Frequently, 4-Always. A minimum of 21 and a maximum of 84 points can be obtained from the inventory. An increase in the score obtained from the inventory indicates an increase in the level of attachment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness group in people with Pregnancy Related, run by Ataturk University.
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 10 inclusion and 5 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 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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 (PSAS) (time frame: Two months). 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 19 Mar 2024.