MindfulnessNCT06403228
The Effect of Mindfulness Based Structured Nursing Interventions on Mental Health Parameters
A study testing Mindfulness Based Structured Nursing Interventions in people with Mindfulness and Mental Health, run by Mersin Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study evaluate the effect of mindfulness-based structured nursing interventions on the mental health parameters of risky pregnant women. The hypothesis of this study is that mindfulness-based structured nursing interventions has an effect of the state-trait anxiety, perceived stress… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Mindfulness, Mental Health
- What is being tested?
- Mindfulness Based Structured Nursing Interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2022to 15 Aug 2023
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 18-65
- Able to read and understand Turkish
- Written informed consent was obtained before participation in the study
- Diagnosed with a risky pregnancy and treated in hospital
- Not receiving any other psychological therapy
- No prior meditation experience
- The participants do not have any physical/mental disability or limitation and disease that would prevent them from participating in the program
Who cannot join
- Under 18 years old
- Cant read and understand Turkish
- Pregnant women who have not been diagnosed a risky pregnancy or treated in hospital
- Meditation or psychological therapy experiences before the study
- The participants who left the program voluntarily or participating in less than 70% of the eight-day program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mindfulness Based Structured Nursing Interventions on Mental Health Parameters of High Risk Pregnant Women
This randomized controlled study evaluate the effect of mindfulness-based structured nursing interventions on the mental health parameters of risky pregnant women. The hypothesis of this study is that mindfulness-based structured nursing interventions has an effect of the state-trait anxiety, perceived stress, depression on high risk pregnant women.
Read the detailed description
Methods: This study, was carried out in three phases. In the first phase, the views and experiences of high-risk pregnant women about being treated in the hospital and in the third phase, their views and experiences about the intervention were determined through individual in-depth interviews.In the second phase, 40 high risk pregnant women were randomly assigned to the study and control groups. The study group (n = 19) received 8 days of mindfulness-based structured nursing interventions. The control group (n = 21) did not receive any intervention. Results were collected through data collection forms before the mindfulness-based structured nursing interventions, after the mindfulness-based structured nursing interventions is completed.
- Conditions
- Mindfulness, Mental Health
- Being tested
- Mindfulness Based Structured Nursing Interventions
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Structured Nursing InterventionsOther
In the study, 8 days of mindfulness-based structured nursing interventions were applied to high-risk pregnant women. The program lasts 60 minutes each day. The program includes short body scanning meditation, breath awareness meditation, sitting meditation, compassion meditation.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The intervention group participated in a mindfulness-based structured nursing interventions program planned for a total of eight days, 60 minutes each day, led by Elçin Alaçam, who has a Mindfulness Institute-approved certificate. The mindfulness-based structured nursing interventions program was structured for 8 days, taking into account the literature and the characteristics of high-risk pregnant women such as length of hospitalization. Receives: Other: Mindfulness Based Structured Nursing Interventions |
| Control Group | No intervention | No intervention was applied to the control group. Data were collected from the control group simultaneously with the study group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety was assessed using the State-Trait Anxiety Scale
The total score obtained from both scales varies between 20 and 80. It states that 0-19 points mean no anxiety, 20-39 points mean mild, 40-59 points mean moderate, 60-79 points mean severe anxiety, and individuals with a score of 60 and above need professional help.
Measured: Change from before intervention up to after intervention, on average 1 week upon completion of the intervention.
Stress was assessed using the Perceived Stress Scale
Total scores range from 0 to 40, with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress, from 14-26 moderate stress, and from 27-40 high perceived stress.
Measured: Change from before intervention up to after intervention, on average 1 week upon completion of the intervention.
Depression was assessed using the Edinburgh Postnatal Despression Scale
Each item is scored 0-3 with a maximum total score of 30. Higher scores indicate a greater severity of symptoms. The most commonly-used cut-offs are ≥ 10 to indicate minor depression and ≥ 13 to indicate major depression.
Measured: Change from before intervention up to after intervention, on average 1 week upon completion of the intervention.
Secondary outcomes (2)
Semi-structured Individual In-Depth Interview Questionnaire I
Semi-structured Individual In-Depth Interview Questionnaire I was created by the researcher in order to evaulate the views and experiences of high risk pregnant women regarding hsopitalization.
Measured: Before the intervention, on average 1 week upon completion of the intervention.
Semi-structured Individual In-Depth Interview Questionnaire II
Semi-structured Individual In-Depth Interview Questionnaire II was created by the researcher in order to evaulate the views and experiences of high risk pregnant women in the study group regarding intervention program.
Measured: After the intervention, on average 1 week upon completion of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start15 Mar 2022
- Primary completion15 Aug 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MindfulnessStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Elcin Alacam, Mersin Training and Research Hospital
- Investigators
- Mualla Yılmaz, Professor, Study director, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403228
- Sponsor's protocol ID
- MersinUniversityNursingFaculty
- Status last verified
- May 2024
- First submitted
- 2 May 2024
- Last updated
- 7 May 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 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness Based Structured Nursing Interventions on Mental Health Parameters of High Risk Pregnant Women
- ClinicalTrials.gov ID
- NCT06403228
- Acronym / sponsor ID
- MersinUniversityNursingFaculty
- Conditions
- Mindfulness, Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mersin Training and Research HospitalOther government
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 7 May 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.
This randomized controlled study evaluate the effect of mindfulness-based structured nursing interventions on the mental health parameters of risky pregnant women. The hypothesis of this study is that mindfulness-based structured nursing interventions has an effect of the state-trait anxiety, perceived stress, depression on high risk pregnant women.
Detailed description
Methods: This study, was carried out in three phases. In the first phase, the views and experiences of high-risk pregnant women about being treated in the hospital and in the third phase, their views and experiences about the intervention were determined through individual in-depth interviews.In the second phase, 40 high risk pregnant women were randomly assigned to the study and control groups. The study group (n = 19) received 8 days of mindfulness-based structured nursing interventions. The control group (n = 21) did not receive any intervention. Results were collected through data collection forms before the mindfulness-based structured nursing interventions, after the mindfulness-based structured nursing interventions is completed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Mindfulness Based Structured Nursing InterventionsThe intervention group participated in a mindfulness-based structured nursing interventions program planned for a total of eight days, 60 minutes each day, led by Elçin Alaçam, who has a Mindfulness Institute-approved certificate. The mindfulness-based structured nursing interventions program was structured for 8 days, taking into account the literature and the characteristics of high-risk pregnant women such as length of hospitalization. |
| Control Group | No intervention | –No intervention was applied to the control group. Data were collected from the control group simultaneously with the study group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Between the ages of 18-65
- Able to read and understand Turkish
- Written informed consent was obtained before participation in the study
- Diagnosed with a risky pregnancy and treated in hospital
- Not receiving any other psychological therapy
Key exclusion criteria (5 listed)
- Under 18 years old
- Cant read and understand Turkish
- Pregnant women who have not been diagnosed a risky pregnancy or treated in hospital
- Meditation or psychological therapy experiences before the study
- The participants who left the program voluntarily or participating in less than 70% of the eight-day program
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 Structured Nursing InterventionsIn the study, 8 days of mindfulness-based structured nursing interventions were applied to high-risk pregnant women. The program lasts 60 minutes each day. The program includes short body scanning meditation, breath awareness meditation, sitting meditation, compassion meditation. | Other | Experimental Group |
Primary outcome
Anxiety was assessed using the State-Trait Anxiety Scale
Time frame: Change from before intervention up to after intervention, on average 1 week upon completion of the intervention.
The total score obtained from both scales varies between 20 and 80. It states that 0-19 points mean no anxiety, 20-39 points mean mild, 40-59 points mean moderate, 60-79 points mean severe anxiety, and individuals with a score of 60 and above need professional help.
Stress was assessed using the Perceived Stress Scale
Time frame: Change from before intervention up to after intervention, on average 1 week upon completion of the intervention.
Total scores range from 0 to 40, with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress, from 14-26 moderate stress, and from 27-40 high perceived stress.
Depression was assessed using the Edinburgh Postnatal Despression Scale
Time frame: Change from before intervention up to after intervention, on average 1 week upon completion of the intervention.
Each item is scored 0-3 with a maximum total score of 30. Higher scores indicate a greater severity of symptoms. The most commonly-used cut-offs are ≥ 10 to indicate minor depression and ≥ 13 to indicate major depression.
2 secondary outcomes
Semi-structured Individual In-Depth Interview Questionnaire I
Time frame: Before the intervention, on average 1 week upon completion of the intervention.
Semi-structured Individual In-Depth Interview Questionnaire II
Time frame: After the intervention, on average 1 week upon completion of the intervention.
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 7 May 2024.
- 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.
Mualla Yılmaz, Professor study director
Mersin 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 Structured Nursing Interventions in people with Mindfulness and Mental Health, run by Mersin Training and Research Hospital 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 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: finished, as of the sponsor's last update on 7 May 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?
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?
Anxiety was assessed using the State-Trait Anxiety Scale (time frame: Change from before intervention up to after intervention, on average 1 week upon completion of the intervention.). 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 7 May 2024.