Effects of a Mindfulness-based Intervention in Stress, Pain and Quality of Life in People Undergoing Hemodialysis

NCT04610593 | Completed

• 1 other identifier: 2019-0017
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This project has as main objective to evaluate the effects of a Mindfulness-based intervention (MBI) in the reduction of stressors, pain and quality of life of people with chronic kidney disease undergoing hemodialysis (HD). The investigators hypothesize that this program offered during hemodialysis sessions may modify the pain profile, stressors levels and may improve the quality of life by the people in hemodialysis. This is an incipient field of research at the international level and almost nonexistent in Brazil. Evidence indicates the need for MBIs to be performed during HD sessions, adapted to the context, to facilitate patient compliance, contribute to the management of the discomfort generated during HD and promote health.

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic; Kidney Diseases; Kidney Insufficiency, Chronic; Chronic Kidney Diseases; End-Stage Kidney Disease

Keywords

End-Stage Kidney Disease; Chronic Kidney Diseases; Renal Dialysis

Outcome Measures

Primary Outcomes (1)

• Pain Acceptance

  The Acceptance \& Action Questionnaire (AAQ-II) is a self-report questionnaire of seven items and aims to measure experiential avoidance. The answers are arranged on a seven-point Likert scale, in which 1 corresponds to "never true" and 7 to "always true". The final scores range from 10 to 70 points, with low scores corresponding to greater acceptance and ability to act in the presence of difficult thinking and emotions.

  Change from Baseline in AAQ-II at 6 months

Secondary Outcomes (10)

• Renal disease and quality of life

  Change from Baseline in KDQOL-SF at 6 months

• Depression, anxiety and stress

  Change from Baseline in DASS-21 at 6 months

• Interest in Mindfulness

  Change from Baseline in Interest in Mindfulness at 6 months

• Level of Mindfulness

  Change from Baseline in FFMQ at 6 months

• Pain Profile

  Change from Baseline in PCP:S at 6 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

This group will receive a Mindfulness-based intervention for 8 weeks, and after the intervention this participants will continuous their treatment as usual

Behavioral: Mindfulness-based Intervention

Treatment as Usual

NO INTERVENTION

Patients in the control group received treatment as usual in the hemodialysis setting: Carry out hemodialysis sessions three times a week, on alternate days, for approximately 4 hours added to appointments and procedures performed by professionals from different areas (medicine, nursing, nutrition, physical education, social work, pharmacy, psychology).

Interventions

Mindfulness-based Intervention BEHAVIORAL

A mindfulness-based intervention will be developed for chronic hemodialysis patients to be performed during hemotherapy sessions. This is an integrative mind-body program, which is based on the MBRP (Bowen et al., 2014) and BMT (T. Russell, 2015) protocols. The program will be conducted in eight weeks, with a weekly individual session of up to 60 minutes facilitated by an instructor, at the bedside during the HD session. The program aims to develop awareness of bodily sensations, emotions and thoughts, with an attitude of openness, curiosity, kindness and non-judgment. During the sessions will be worked four main techniques of mindfulness meditation: mindfulness in breathing, body scanning, conscious movements and practice of compassion. Participants are invited and encouraged to practice Mindfulness using audios made available during the other HD sessions they undergo during the week, in addition to daily home practice.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Higher than 18 years old;
• Undergoing hemodialysis for at least three months;
• Auditory acuity to listen to Mindfulness practices;
• Be interested in the objectives of this study and be randomized in one of the two groups (MBI or TAU).

You may not qualify if:

• Severe cognitive impairment or severe psychiatric disorder diagnosed by the medical staff of the nephrology unit;
• Suicidal ideation.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-007, Brazil

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic; Kidney Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency; 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

• Angélica N Adamoli, MD

  Nephrology Service Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 30, 2020
• Study Start: May 6, 2019
• Primary Completion: July 8, 2019
• Study Completion: August 20, 2020
• Last Updated: December 22, 2021

Record last verified: 2021-12

Locations

BR (1)