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NCT Number: NCT06403228

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mersin University

Mersin, 33343, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Anxiety was assessed using the State-Trait Anxiety Scale

    Time frame: 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.

  2. Stress was assessed using the Perceived Stress Scale

    Time frame: 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.

  3. Depression was assessed using the Edinburgh Postnatal Despression Scale

    Time frame: 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.

Secondary outcomes

  1. Semi-structured Individual In-Depth Interview Questionnaire I

    Time frame: 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.

  2. Semi-structured Individual In-Depth Interview Questionnaire II

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mersin Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 7, 2024
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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