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NCT Number: NCT06404957

Effect of Mindfulness-based Applied to Hemodialysis Patients on Psychosocial Adaptation

The goal of this clinical study is to adapt mindfulness-based nursing interventions to hemodialysis patients and to investigate their effects on their psychosocial adjustment.

The main question[s] it aims to answer are:

Do consciously applied nursing interventions increase the psychosocial adjustment to the disease in hemodialysis patients? Do mindfulness-based nursing interventions increase body and mind awareness in hemodialysis patients? Researchers will compare the experimental and control groups to see if mindfulness-based interventions have an effect on the psycho-social adjustment of hemodialysis patients.

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Key information

Conditions

Hemodialysis Psychosocial Adaptation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Çiğdem Şen Tepe

Sakarya, 54050, Turkey (Türkiye)

About this study

Primary Aims Test the efficacy of an adapted Mindfulness-Based Stress Reduction program to reduce symptoms and improve psychosocial adaption by 6 weeks.

Hypotheses

Primary: The mindfulness-based program increases the psychosocial adjustment to the disease in hemodialysis patients.

Secondary: Mindfulness-based program increases body and mind awareness in hemodialysis patients.

Long-range Goal: To develop evidence-based recommendations for non-pharmacologic strategies that provide psychosocial adaptation relief to hemodialysis patients and are safe, practical, and cost-effective.

Interventions: The Mindfulness-based Applied program includes the curricular content of the standard 6 week. A trained teacher provides instruction in meditation techniques, including body scan, standing, sitting, and walking meditations, and mindful yoga.

The attention control consists of 90-minute online workshops. Audio recordings and written materials related to awareness exercises will be given to the participants at the end of each session so that they can do home practices.

Recruiting Methods:

It will consist of hemodialysis patients receiving service from hemodialysis centers located in a province in the west of Turkey. The sample of the study will consist of individuals who voluntarily agree to participate in the study and who comply with the research criteria.

Data Collection Tools Mindfulness scale: Mindful Awareness Attention Scale (MAAS) The psychosocial adjustment to illness scale (PAIS-SR) Hemodialysis Stressor Scale (HSS)

Study Design: Randomized controlled experimental study

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Receiving hemodialysis treatment
  • Between the ages of 18-65

Exclusion criteria

  • Patients with acute renal failure
  • Current hospitalization, current ongoing chemotherapy or radiotherapy
  • Cognitive dysfunction or mental retardation
  • Current substance abuse
  • Entering hemodialysis due to current psychotropic drug use

Treatment and study plan

Mindfulness-based Applied

Behavioral

Mindfulness-Based Practices is planned to be an 8-week program of mindfulness meditation and gentle Hatha yoga taught in an online class for up to 14 participants.

Active Comparator: Control groups

Behavioral

No intervention will be made in this group.

Primary outcomes

  1. Mindfulness-Based Practice Applied to Hemodialysis Patients

    Time frame: 6 weeks

    Awareness-Based Practice Applied to Haemodialysis Patients is expected to affect the psychosocial adaptation of patients to their diseases.. Psychosocial Adjustment to Illness Self-Report Scale (PAIS-SR) was used to assess this outcome measure. Each item is scored on a scale ranging from 0 to 3. Largely negative differences since the disease are evaluated with a score of 3 and positive differences with a score of 0. In studies conducted with PAIS-SR, scores lower than 35 are evaluated as good psychosocial adjustment, scores between 35-51 as moderately good psychosocial adjustment, and scores higher than 51 as poor adjustment.

Sponsors and collaborators

Lead sponsor

Sakarya University

Other

Registry information

Official study title

The Effect of Mindfulness-based Nursing Interventions Applied to Hemodialysis Patients on Psychosocial Adaptation

Acronym: EMBAHPPA

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 8, 2024
Registry last updated
May 8, 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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