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

Not Applicable

Completed

• Conditions: Mental Health; Mindfulness

• Registration Number: NCT06403228
• Lead Sponsor: Mersin Training and Research Hospital

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.

Study Timeline

• Study Start: 2022-03-15
• Primary Completion: 2023-08-15
• Study Completion: 2023-08-15
• Status Verified: 2024-05
• Study First Submitted: 2024-05-02
• Study First Submitted QC: 2024-05-06
• Last Update Submitted: 2024-05-06
• Study First Posted: 2024-05-07
• Last Update Posted: 2024-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anxiety was assessed using the State-Trait Anxiety Scale	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.
Depression was assessed using the Edinburgh Postnatal Despression Scale	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.
Stress was assessed using the Perceived Stress Scale	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.

Secondary Outcome Measures

Name	Time	Method
Semi-structured Individual In-Depth Interview Questionnaire II	After 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.
Semi-structured Individual In-Depth Interview Questionnaire I	Before 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.

Trial Locations

Locations (1)

Mersin University; 🇹🇷 Mersin, Turkey