The Effect of Second Level Reiki on Pain Severity and Quality of Life in Patients Receiving Hemodialysis Treatment

NCT06519136 | Recruiting

• 1 other identifier: Distance Reiki
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: The aim of this study is to determine the effect of 20-minute second-level Reiki application for 4 consecutive days on pain intensity and quality of life in patients receiving hemodialysis (HD) treatment and It is a comparison of the follow-up results of the first level Reiki applied within the scope of the doctoral thesis and the second level Reiki applications to be applied within the scope of this study. Method: The study will be conducted as a pre-test-post-test, double-blind, randomized controlled trial. After obtaining Ethical Committee approval, participants in the Reiki group will receive 20-minute Reiki sessions at the second level daily from 7:00 PM to 9:00 PM for four days, while participants in the sham Reiki group will be informed that distant energy application will be performed but no actual treatment will be administered. The researcher will plan to administer second-level Reiki sessions to 8 patients daily. Throughout the study, patients in both groups will continue their routine treatments. At the beginning and three weeks after the end of the intervention, Kidney Disease Quality of Life Scale (KDQOLTM-36) scores will be collected face-to-face at HD centers, before and after the intervention Visual Analog Scale for Pain (VAS-Pain), additionally, psychodynamic responses experienced during the first and last Reiki sessions will be evaluated by three blinded assessors via telephone in both study groups. Results: Statistical analyses of the data will be conducted using the Statistical Package for Social Sciences (Version 22.0, SPSS Inc., Chicago, IL, USA, License: Hitit University). Depending on the homogeneity of the data distribution, appropriate parametric or nonparametric tests will be performed for data evaluation.

Conditions

Hemodialysis

Keywords

Hemodialysis; Distance Reiki; Pain; Quality of life; Nursing

Outcome Measures

Primary Outcomes (2)

• Pain severity measurement

  "Visual Analog Scale (VAS-Pain)" was applied to the patients in the Reiki and sham Reiki groups before and after application. In VAS-Pain, 1-3 cm is considered a "mild pain" score, 4-6 cm is considered a "moderate pain" score, and 7-10 cm is considered a "severe pain" score.

  Day 1

• Initial quality of life measurement

  Initial quality of life measurement, "Kidney Disease Quality of Life -KDQOLTM-36" were applied to the patients in the Reiki and sham Reiki groups. Scores in each subscale of the KDQOLTM-36 scale range from 0 to 100, with higher scores indicating better health-related quality of life.

  Day 1

Secondary Outcomes (2)

• Pain severity measurement at the end of the 4th session

  Day 4

• Quality of life measurement at the end of 4 week later

  4 week later

Study Arms (2)

Distance Reiki Group

EXPERIMENTAL

According to Usui, the second level Reiki application will be applied for 20 minutes a day between 19.00 and 21.00 in the evening for four consecutive days by the researcher who has completed his second level training, in accordance with the "Second Level Reiki Application Protocol".

Other: Distance Reiki

Sham Reiki Group

SHAM COMPARATOR

It will be stated that remote energy application will be applied to the Sham Reiki group and no application will be made.

Other: Sham Reiki

Interventions

Distance Reiki OTHER

According to Usui, the second level Reiki application will be applied for 20 minutes a day between 19.00 and 21.00 in the evening for four consecutive days by the researcher who has completed his second level training, in accordance with the "Second Level Reiki Application Protocol".

Distance Reiki Group

Sham Reiki OTHER

It will be stated that remote energy application will be applied to the Sham Reiki group and no application will be made.

Sham Reiki Group

Eligibility Criteria

• Age: 28 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who volunteered to participate in the research and received first level Reiki within the scope of the study titled "The effect of Reiki application on pain severity and quality of life in patients receiving hemodialysis treatment",
• In patients over 65 years of age, patients with a Standardized Mini Mental Test (SMMT) score of 24 points and above will be included in the sample.

You may not qualify if:

• Those who do not volunteer to participate in the research,
• Deceased,
• Changing the treatment center,
• Starting to receive peritoneal dialysis treatment or having renal transplantation,
• Using another complementary integrative therapy application,
• In patients over 65 years of age, patients with an SMMT value below 24 will not be included in the sample.

Sponsors & Collaborators

• Mersin University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Sultan Çeçen

Çorum, 19030, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Yilmaz CK, Karakoyun A, Yurtsever S. The Effect of Distant Reiki Applied to Individuals with Extremity Amputation on Pain Level and Holistic Well-Being: A Quasi-experimental Study. Pain Manag Nurs. 2024 Apr;25(2):e87-e92. doi: 10.1016/j.pmn.2023.11.003. Epub 2023 Nov 28.

  PMID: 38030555 BACKGROUND

• Unal N, Bektas Akpinar N, Bek D, Yurtsever S. The Effect of Reiki on Pain, Functional Status, and Holistic Well-Being in Patients With Knee Osteoarthritis: A Randomized Controlled Trial. Orthop Nurs. 2024 Mar-Apr 01;43(2):109-118. doi: 10.1097/NOR.0000000000001017.

  PMID: 38546686 BACKGROUND

• Cecen S, Tasci S. Impact of Reiki Levels 1 and 2 on Pain and Quality of Life Among Hemodialysis Patients: A Comparative Study. J Holist Nurs. 2025 Nov 20:8980101251393300. doi: 10.1177/08980101251393300. Online ahead of print.

  PMID: 41264460 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sultan Çeçen

CONTACT

+90 364 223 15 61; sultancecen@hitit.edu.tr

Sultan Taşcı

CONTACT

+90 352 207 66 66; sultant@erciyes.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The three interviewers responsible for data collection and the patients will be blinded as to which group they are in. According to the lists created after block randomization in the computer environment, the researcher will obtain written consent from those who agree to participate in the research. Patients in both groups will be blinded by stating that they will receive Reiki treatment remotely. In addition, until the end of the research, the group the patient is in will not be written on the data collection forms, and all three interviewers will be blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer PhD

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 25, 2024
• Study Start: October 1, 2024
• Primary Completion: October 28, 2024
• Study Completion: December 14, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

TU (1)