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

Mental Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06403228
• Other study ID #: MersinUniversityNursingFaculty
• Status: Completed
• Phase: N/A
• Start date: March 15, 2022
• Est. completion date: August 15, 2023

Study information

• Verified date: May 2024
• Source: Mersin Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, depression on high risk pregnant women.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 15, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Health
• Mindfulness

Intervention

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.

Locations

Country	Name	City	State
Turkey	Mersin University	Mersin

Sponsors (1)

Lead Sponsor	Collaborator
Mersin Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.