The Effect of Mindfulness on Emotional Regulations Skills and Quality of Life Among Patients on Hemodialysis

NCT06622200 | Not Yet Recruiting

• 1 other identifier: 136-2024
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to investigate how mindfulness-based intervention (MBI) impacts trait mindfulness, cognitive reappraisal, expressive suppression and quality of life in patients with end-stage renal disease (ESRD) undergoing hemodialysis. A Randomized controlled trial will be conducted with patients diagnosed with ESRD and undergoing hemodialysis treatment. Participants selected using a convenience sampling method will be randomly assigned into the intervention group (n=52) who received MBI, and the control group (n=52) who received a similar intervention after the study. The intervention involves a 30-minute MBI introduced three sessions per week during hemodialysis sessions over five weeks. Outcome measures included the Mindful Attention Awareness Scale (MAAS) to assess trait mindfulness, the Emotion Regulation Questionnaire (ERQ) for cognitive reappraisal and behavioral suppression, and the Kidney Disease-related Quality of Life Questionnaire for quality of life. Data were collected at baseline and post-intervention.

Conditions

End-Stage Kidney Disease

Keywords

hemodialysis; Cognitive reappraisal; Behavioral suppression; mindfulness; quality of life

Outcome Measures

Primary Outcomes (1)

• kidney Disease- related Quality of Life questionnaire

  The Arabic version of the kidney disease- related Quality of Life questionnaire (KDQOL-36) was used to evaluate quality of life. It has four subscales: symptoms and problems (12 items); burden of kidney disease (4 items); effects of kidney disease (8 items); and generic core \[Physical Component Summary (PCS, 12 items) and mental component summary (MCS, 12 items) (Elamin et al., 2019). Each item\'s raw, pre-coded numerical values are converted linearly to a scale from 0 to 100, where higher numbers indicate better quality of life (Kalantar-Zadeh \& Unruh, 2005). The Arabic version of the scale revealed favorable psychometric attributes in Arabic patients with chronic renal insufficiency and The KDQOL-36 translation showed a Cronbach\'s alpha of 0.81, demonstrating strong internal reliability (Alhawatmeh et al., 2022; Elamin et al., 2019).

  From enrollment to the end of treatment at 6 weeks

Secondary Outcomes (2)

• Emotional Regulation Questionnaire

  From enrollment to the end of treatment at 6 weeks

• Mindful Attention Awareness Scale

  From enrollment to the end of treatment at 6 weeks

Study Arms (2)

Mindfulness-based intervention

EXPERIMENTAL

The standardized, theory based MBI was introduced to the experimental group (Smith, 2005). This 30-minute protocol involves a series of activities, including paying attention to and being aware of breath, body sensations, thoughts, and sounds without judgment. This protocol is a widely recognized and utilized method due to its simplicity and accessibility, making it an ideal choice for this study (Alhawatmeh et al., 2022; Smith, 2005). Participants completed three weekly sessions of MBI for five weeks during their hemodialysis treatments (Alhawatmeh et al., 2022). Participants were provided with audio recordings of the MBI protocol, which they could practice during hemodialysis sessions. These recordings were delivered via email and WhatsApp, depending on their preference. This audio recording was developed based on the Smith's protocol by a certified study researcher who had a higher degree in nursing and extensive experience in practicing MBI.

Behavioral: Mindfulness-based Intervention

Control Group

NO INTERVENTION

The control group did not receive any intervention from the researcher.

Interventions

Mindfulness-based Intervention BEHAVIORAL

In the present research, the standardized, theory based MBI was introduced to the experimental group (Smith, 2005). This 30-minute protocol involves a series of activities, including paying attention to and being aware of breath, body sensations, thoughts, and sounds without judgment. This protocol is a widely recognized and utilized method due to its simplicity and accessibility, making it an ideal choice for this study. Participants in the experimental group completed three weekly sessions of MBI for five weeks during their hemodialysis treatments (Alhawatmeh et al., 2022). Participants were provided with audio recordings of the MBI protocol, which they could practice during hemodialysis sessions. These recordings were delivered via email and WhatsApp, depending on their preference. This audio recording was developed based on the Smith's protocol by a certified study researcher who had a higher degree in nursing and extensive experience in practicing and delivering MBIs.

Mindfulness-based intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with ESRD undergoing hemodialysis at least three sessions a week
• Being at least 18 years old
• Having a smartphone
• Being capable of reading and writing in Arabic

You may not qualify if:

• Patients under psychotherapy or taking regular psychopharmacological and analgesic treatment

Sponsors & Collaborators

• Jordan University of Science and Technology: lead

Study Sites (1)

Prince Rashid Military Hospital

Irbid, 22110, Jordan

Location

Related Publications (48)

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MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hossam Alhawatmeh, Doctoral degree

  Hossam alhawatmeh, associate professor, Jordan university of science and technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hossam Alhawatmeh N Associate Professor, Doctoral degree

CONTACT

00962-79-741-3244; hnhawatmeh@just.edu.jo

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 2, 2024
• Study Start: October 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: October 2, 2024

Record last verified: 2024-09

Locations

JO (1)