Clinical trial NCT06403228: The Effect of Mindfulness Based Structured Nursing Interventions on Mental Health Parameters
Official title: The Effect of Mindfulness Based Structured Nursing Interventions on Mental Health Parameters of High Risk Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness
Mental Health
Lead sponsor: Mersin Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-05-07
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Anxiety was assessed using the State-Trait Anxiety Scale
timeFrame: Change from before intervention up to after intervention, on average 1 week upon completion of the intervention.
measure: Stress was assessed using the Perceived Stress Scale
timeFrame: Change from before intervention up to after intervention, on average 1 week upon completion of the intervention.
measure: Depression was assessed using the Edinburgh Postnatal Despression Scale
timeFrame: Change from before intervention up to after intervention, on average 1 week upon completion of the intervention.
Secondary outcomes:
measure: Semi-structured Individual In-Depth Interview Questionnaire I
timeFrame: Before the intervention, on average 1 week upon completion of the intervention.
measure: Semi-structured Individual In-Depth Interview Questionnaire II
timeFrame: After the intervention, on average 1 week upon completion of the intervention.
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Mersin University
Study officials:
affiliation: Mersin University
name: Mualla Yılmaz, Professor
role: STUDY_DIRECTOR
References: