NCT06772467

Brief Summary

Objective: This study was conducted to evaluate the effect of reiki and emotional release technique (EFT) on symptom burden, disease adaptation, vital signs and catheter-related pain in haemodialysis patients. Method: The study was conducted as a pretest-posttest randomised controlled experimental research model. The study was conducted in two haemodialysis units in Bingöl province between September 2023 and December 2024. The population of the study consisted of all patients receiving treatment in haemodialysis units, and the sample consisted of 96 patients (Reiki group =32, EFT group =32 and control group =32 people) determined by power analysis. "Dialysis symptom index", " Tee end-stage renal failure adjustment scale", "Vital signs follow-up form" and "Visual analogue scale" were used for data collection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 31, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 13, 2025

Completed
Last Updated

January 13, 2025

Status Verified

January 1, 2025

Enrollment Period

1.2 years

First QC Date

December 31, 2024

Last Update Submit

January 8, 2025

Conditions

Keywords

ReikiEFTHemodialysisPainSymptom

Outcome Measures

Primary Outcomes (4)

  • The effect of Reiki on dialysis symptoms

    Reiki was applied to this group twice a week for 4 weeks by a researcher who had a Reiki application certificate. Reiki sessions were applied to the patients before haemodialysis and the session duration was approximately 35-40 minutes. Pre and post data were obtained 'Dialysis Symptom Index'. This index aims to measure the physical and emotional symptoms and their severity experienced by haemodialysis patients in the last seven days. The index consists of 30 items in total and each item describes a different physical or emotional symptom. The symptoms experienced are answered as yes or no, and if the answer is yes, how much this symptom affects the individual is evaluated on a 5-point Likert scale (0: not at all, 4: very much). The score that can be obtained from the index ranges from 0 to 150, and an increase in the score indicates an increase in the severity of the symptom.

    2 month

  • The effect of Reiki on compliance to illness

    Reiki was applied to this group twice a week for 4 weeks by a researcher who had a Reiki application certificate. Reiki sessions were applied to the patients before haemodialysis and the session duration was approximately 35-40 minutes. Pre and post data were obtained 'End Stage Renal Failure Compliance Scale'. This scale consists of four dimensions to assess patients' participation in haemodialysis treatment, medication use, fluid restriction and compliance with dietary recommendations. Each domain has its own scoring system. Scores ranging from 0 to 1200 can be obtained from the scale. An increase in the score indicates an increase in compliance with the disease.

    2 month

  • The effect of Reiki on vital sings

    Reiki was applied to this group twice a week for 4 weeks by a researcher who had a Reiki application certificate. Reiki sessions were applied to the patients before haemodialysis and the session duration was approximately 35-40 minutes. Pre and post data were obtained "Vital Signs Monitoring Form". The vital signs of the patients were measured and recorded 3 times: before each Reiki session, after the Reiki session, just before the patient entered haemodialysis and after the haemodialysis session.

    2 month

  • The effect of Reiki on catheter-related pain

    Reiki was applied to this group twice a week for 4 weeks by a researcher who had a Reiki application certificate. Reiki sessions were applied to the patients before haemodialysis and the session duration was approximately 35-40 minutes. Pre and post data were obtained 'Pain Intensity Measurement-Visual Analogue Scale (VAS)' to measure catheter intervention pain. After each session, patients with fistula were asked to mark the level of pain felt during catheter insertion on a visual analogue scale.

    2 month

Secondary Outcomes (4)

  • The effect of EFT on dialysis symptoms

    2 months

  • The effect of EFT on compliance to illness

    2 months

  • The effect of EFT on vital sings

    2 months

  • The effect of EFT on catheter-related pain

    2 months

Study Arms (3)

Reiki group

EXPERIMENTAL

Reiki

Behavioral: Intervention (Reiki)

EFT group

EXPERIMENTAL

EFT

Behavioral: EFT

Control group

NO INTERVENTION

No intervention

Interventions

Reiki was applied to this group twice a week for 4 weeks by a researcher who had a Reiki application certificate. Reiki sessions were applied to the patients before haemodialysis and the session duration was approximately 35-40 minutes. Reiki is applied to the seven major chakras and many minor chakras in the body. The chakras are located in the centre of the body, on a vertical line, in the front and back of the body. In this study, Reiki was applied to the patients twice a week for 4 weeks. Reiki sessions were performed before haemodialysis and each session lasted approximately 35-40 minutes. The vital signs of the patients were measured and recorded 3 times: before each Reiki session, after the Reiki session, just before the patient entered haemodialysis and after the haemodialysis session. After each session, patients with fistula were asked to mark the level of pain felt during catheter insertion on a visual analogue scale.

Reiki group
EFTBEHAVIORAL

Emotional Freedom Technique (EFT) is a method that helps people manage their emotions and disturbing thoughts, helping to reduce their stress and anxiety. EFT is also called tapping. EFT sessions were applied to the patients before haemodialysis and the session duration was approximately 35-40 minutes. Patients received 8 sessions of EFT. The vital signs of the patients were measured and recorded 3 times: before each EFT session, after the reiki session, just before the patient entered haemodialysis and after the haemodialysis session. After each session, patients with fistula were asked to mark the level of pain felt during catheter insertion on a visual analogue scale.

EFT group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be over 18 years old,
  • To agree to participate in the research,
  • To be literate,
  • To be able to communicate verbally,
  • Receiving three sessions of outpatient haemodialysis (HD) treatment per week in the same institution,
  • Active use of the fistula,
  • No impairment in mental and cognitive functions,
  • Receiving HD therapy for at least three months (to be considered a chronic HD programme)

You may not qualify if:

  • Refusal to participate in research,
  • Receiving peritoneal dialysis,
  • To have a central venous catheter,
  • A psychiatric disorder diagnosed by a psychiatrist,
  • To withdraw from the investigation,
  • Losing your life in the process of work,
  • Change of institution or city,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, 44800, Turkey (Türkiye)

Location

Related Publications (1)

  • Aslan H, Pekince H. Nursing students' views on the COVID-19 pandemic and their percieved stress levels. Perspect Psychiatr Care. 2021 Apr;57(2):695-701. doi: 10.1111/ppc.12597. Epub 2020 Aug 17.

MeSH Terms

Conditions

Pain

Interventions

MethodsTherapeutic Touch

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative TechniquesMind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual Therapies

Study Officials

  • Hakime Aslan

    Inonu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 31, 2024

First Posted

January 13, 2025

Study Start

September 25, 2023

Primary Completion

December 20, 2024

Study Completion

December 30, 2024

Last Updated

January 13, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations