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

NCT06403228 | Completed

• 1 other identifier: MersinUniversityNursingFaculty
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Mindfulness; Mental Health

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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 II

  After the intervention, on average 1 week upon completion of the intervention.

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

Mindfulness Based Structured Nursing Interventions 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.

Experimental Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: High risk pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mersin Training and Research Hospital: lead

Study Sites (1)

Mersin University

Mersin, 33343, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Mualla Yılmaz, Professor

  Mersin University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc, Nurse, Principal Investigator

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 7, 2024
• Study Start: March 15, 2022
• Primary Completion: August 15, 2023
• Study Completion: August 15, 2023
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)