A Guided Meditation Program in Patients Undergoing Dialysis

NCT04155216 | Completed

• 1 other identifier: 1706018340
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, single center, non-randomized, single-arm pilot study to determine the ability of a Relaxation and Guided Imagery Program for its ability to induce a reduction in anxiety in subjects undergoing hemodialysis for End Stage Renal Disease (ESRD). Measures will evaluate the program's ability to impact anxiety, with secondary analysis of headaches, insomnia, fatigue, and pain. Subjects will be administered questionnaires at the study start and study end. Intervention will involve listening to a pre-recorded guided relaxation and imagery during regularly-scheduled dialysis sessions for four weeks.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (2)

• Quality of Life Score

  To determine the quality of life using the Kidney Disease and Quality of Life (KDQOL) questionnaire. The score is determined by transforming the raw precoded numeric values of items to a 0-100 possible range, with higher transformed scores always reflecting better quality of life. Each item is put on a 0-100 range so that the lowest and highest possible score are set at 0 and 100 respectively. Scores represent the percentage of total possible score achieved.

  Four weeks

• Anxiety level

  To determine how much of an impact anxiety had on the subject's day to day life, using a Likert Scale, ranging from 1 (none) to 5 (extreme).

  Four weeks

Secondary Outcomes (5)

• Inflammation level

  Four weeks

• Headaches

  Four weeks

• Insomnia

  Four weeks

• Fatigue

  Four weeks

• Feeling pain

  Four weeks

Study Arms (1)

Guided imagery

EXPERIMENTAL

Relaxation and guided imagery program

Behavioral: Relaxation and guided imagery program

Interventions

Relaxation and guided imagery program BEHAVIORAL

Listening to a relaxation and guided imagery program for 25 minutes during hemodialysis treatments.

Guided imagery

Eligibility Criteria

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

You may qualify if:

• Males and females; 18 years or older.
• Receiving hemodialysis at The Rogosin Institute for End Stage Renal Disease.
• Willingness to adhere to the treatment intervention schedule.
• Subjects must present with anxiety.
• Willing and able to provide informed consent.

You may not qualify if:

• Plans to withdraw from dialysis at The Rogosin Institute within the study timeline.
• Unable to provide informed consent.

Sponsors & Collaborators

• The Rogosin Institute: lead
• Weill Medical College of Cornell University: collaborator

Study Sites (1)

The Rogosin Institute

New York, New York, 10021, United States

Location

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

• Andrew Bohmart, MD

  The Rogosin Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: November 7, 2019
• Study Start: January 6, 2020
• Primary Completion: October 7, 2020
• Study Completion: October 7, 2020
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)