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

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.

Study Overview

• Status: Completed
• Conditions: Mental Health; Mindfulness
• Intervention / Treatment: Other: Mindfulness Based Structured Nursing Interventions

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Mersin, Turkey, 33343
    • Mersin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; 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.	Other: Mindfulness 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.
No Intervention: Control Group; No intervention was applied to the control group. Data were collected from the control group simultaneously with the study group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Change from before intervention up to after intervention, on average 1 week upon completion of the intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	After the intervention, on average 1 week upon completion of the intervention.

Collaborators and Investigators

• Sponsor: Mersin Training and Research Hospital
• Investigators: Study Director: Mualla Yılmaz, Professor, Mersin University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Actual): August 15, 2023
• Study Completion (Actual): August 15, 2023

Study Registration Dates

• First Submitted: May 2, 2024
• First Submitted That Met QC Criteria: May 6, 2024
• First Posted (Actual): May 7, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: MersinUniversityNursingFaculty

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No