The Effect of Sujok Therapy on Symptom Burden and Comfort Level in Patients Undergoing Hemodialysis Treatment

NCT05939505 | Unknown

• 1 other identifier: GaziosmanpasaU-HMŞRLK-CD-01
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

Many symptoms such as fatigue, muscle cramps, dry mouth, and headache that develop in patients due to the hemodialysis treatment process affect the quality of life and comfort of people. Sujok therapy is an effective method in symptom management. Although sujok therapy is an uncomplicated acupressure, it has positive features such as being uncomplicated so that it can be applied by the patients themselves. This study is planned as a single-blind placebo-controlled randomized trial. Research Hypotheses H0/1: Hydrotherapy has no effect on symptom burden in hemodialysis patients. H0/2: Hydrotherapy has no effect on hemodialysis comfort in hemodialysis patients. H1/1: Hydrotherapy has an effect on symptom burden in hemodialysis patients. H1/2: Hydrotherapy has an effect on hemodialysis comfort in hemodialysis patients. Inclusion criteria of volunteers

1. 1.18 years or older
2. 2.To be on HD treatment for at least 6 months In our study, there are three groups as experimental, placebo and control groups.

Conditions

Dialysis; Complications

Keywords

dialysis, Su Jok therapy, nursing

Outcome Measures

Primary Outcomes (1)

• Symptom burden in hemodialysis patients

  Dialysis Symptom Index

  pre-therapy, up to 3 weeks, up to 5 weeks

Secondary Outcomes (1)

• hemodialysis comfort in hemodialysis patients

  pre-therapy, up to 3 weeks, up to 5 weeks

Study Arms (3)

Su Jok Therapy Group

EXPERIMENTAL

Su jok Therapy According to Sujok therapy, sujok therapy will be applied 14 times with an interval of one day with Mexican bean seeds on the points representing the kidney.

Other: Su Jok therapy; Other: routine interventions

placebo group

PLACEBO COMPARATOR

Instead of the Mexican bean seed used in Sujok therapy, plastic beans will be applied 14 times with an interval of one day.

Other: placebo; Other: routine interventions

Control group

ACTIVE COMPARATOR

Routine applications will be made in the Dialysis Unit.

Other: routine interventions

Interventions

Su Jok therapy OTHER

Sujok therapy will be applied with Mexican bean seeds 14 times with an interval of one day.

Su Jok Therapy Group

placebo OTHER

Instead of the Mexican bean seed applied in sujok therapy, plastic beans will be applied 14 times with an interval of one day.

placebo group

routine interventions OTHER

routine applications in the hemodialysis unit

Control group; Su Jok Therapy Group; placebo group

Eligibility Criteria

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

You may qualify if:

• be 18 years or older
• Receiving hemodialysis treatment for at least 6 months
• agreeing to participate in the study

You may not qualify if:

• Having food, metal and plastic allergies
• Having a cognitive and psychiatric diagnosis
• Loss of sensation and amputation that prevents application in the feet

Sponsors & Collaborators

• Candan DOGAN: lead
• Ataturk University: collaborator

Central Study Contacts

Candan DOĞAN, lecturer

CONTACT

+90 (356) 250 00 11; dogancandan70@gmail.com

Mehtap TAN, professor Doctor

CONTACT

+90 442 231 1339; mtan@atauni.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will not know which group they are in. The person who analyzes the data obtained at the end of the study will not know the groups.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Instructor

Model Details: randomized-controlled,placebo

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: July 11, 2023
• Study Start: September 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: November 1, 2023
• Last Updated: August 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR