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The Effect of Mindfulness Based Structured Nursing Interventions on Mental Health Parameters

The Effect of Mindfulness Based Structured Nursing Interventions on Mental Health Parameters of High Risk Pregnant Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06403228
Enrollment
40
Registered
2024-05-07
Start date
2022-03-15
Completion date
2023-08-15
Last updated
2024-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Health, Mindfulness

Brief 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, 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.

Interventions

OTHERMindfulness Based Structured Nursing Interventions

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.

Sponsors

Mersin Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Anxiety was assessed using the State-Trait Anxiety ScaleChange 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 ScaleChange 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 ScaleChange 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.

Secondary

MeasureTime frameDescription
Semi-structured Individual In-Depth Interview Questionnaire IBefore the intervention, on average 1 week upon completion of the intervention.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.
Semi-structured Individual In-Depth Interview Questionnaire IIAfter the intervention, on average 1 week upon completion of the intervention.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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026