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

NCT ID: NCT06403228

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-15
• Study Completion Date: 2023-08-15

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.

Conditions

Mindfulness; Mental Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Mindfulness Based Structured Nursing Interventions

Intervention Type: OTHER

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.

Control Group

No intervention was applied to the control group. Data were collected from the control group simultaneously with the study group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mersin Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Elcin Alacam

MSc, Nurse, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mualla Yılmaz, Professor

Role: STUDY_DIRECTOR

Mersin University

Locations

Mersin University

Mersin, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

MersinUniversityNursingFaculty

Identifier Type: -

Identifier Source: org_study_id