Hemodialysis PatientReiki-EFTNCT06772467
The Effect of Reiki and EFT on Symptom Burden, Disease Adaptation, Vital Signs and Catheter-Related Pain in HD Patients
A study testing Intervention (Reiki) and EFT in people with Hemodialysis Patient, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemodialysis Patient
- What is being tested?
- Intervention (Reiki) and EFT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Sep 2023to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Reiki and Emotional Release Technique (EFT) on Symptom Burden, Disease Adaptation, Vital Signs and Catheter-Related Pain in Haemodialysis Patients:Randomized Controlled Trial
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.
Read the detailed description
During the research process, 8 sessions of reiki and EFT were applied to the patients in the experimental groups, while the patients in the control group continued to receive routine care practices.
- Conditions
- Hemodialysis Patient
- Being tested
- Intervention (Reiki), EFT
- Keywords
- Reiki, EFT, Hemodialysis, Pain, Symptom
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention (Reiki)Behavioural
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.
EFTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Reiki group | Experimental | Reiki Receives: Behavioral: Intervention (Reiki) |
| EFT group | Experimental | EFT Receives: Behavioral: EFT |
| Control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 month
Secondary outcomes (4)
The effect of EFT on dialysis symptoms
EFT was applied to this group twice a week for 4 weeks by a researcher who had a EFT application certificate. EFT 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.
Measured: 2 months
The effect of EFT on compliance to illness
EFT was applied to this group twice a week for 4 weeks by a researcher who had a EFT application certificate. EFT 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.
Measured: 2 months
The effect of EFT on vital sings
EFT was applied to this group twice a week for 4 weeks by a researcher who had a EFT application certificate. EFT 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 EFT session, after the EFT session, just before the patient entered haemodialysis and after the haemodialysis session.
Measured: 2 months
The effect of EFT on catheter-related pain
EFT was applied to this group twice a week for 4 weeks by a researcher who had a EFT application certificate. EFT 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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start25 Sep 2023
- Primary completion20 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemodialysis PatientStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakime Aslan, Inonu University
- Investigators
- Hakime Aslan, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772467
- Sponsor's protocol ID
- hanife çelik
- Acronym
- Reiki-EFT
- Status last verified
- Jan 2025
- First submitted
- 31 Dec 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32808314
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reiki and Emotional Release Technique (EFT) on Symptom Burden, Disease Adaptation, Vital Signs and Catheter-Related Pain in Haemodialysis Patients:Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06772467
- Acronym / sponsor ID
- Reiki-EFT / hanife çelik
- Conditions
- Hemodialysis Patient
- Keywords
- Reiki, EFT, Hemodialysis, Pain, Symptom
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
During the research process, 8 sessions of reiki and EFT were applied to the patients in the experimental groups, while the patients in the control group continued to receive routine care practices.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Reiki group | Experimental | Behavioral: Intervention (Reiki)Reiki |
| EFT group | Experimental | Behavioral: EFTEFT |
| Control group | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention (Reiki)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. | Behavioural | Reiki group |
| EFTEmotional 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. | Behavioural | EFT group |
Primary outcome
The effect of Reiki on dialysis symptoms
Time frame: 2 month
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.
The effect of Reiki on compliance to illness
Time frame: 2 month
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.
The effect of Reiki on vital sings
Time frame: 2 month
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.
The effect of Reiki on catheter-related pain
Time frame: 2 month
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.
4 secondary outcomes
The effect of EFT on dialysis symptoms
Time frame: 2 months
The effect of EFT on compliance to illness
Time frame: 2 months
The effect of EFT on vital sings
Time frame: 2 months
The effect of EFT on catheter-related pain
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Results publication: PubMed 32808314Aslan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hakime Aslan principal investigator
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention (Reiki) and EFT in people with Hemodialysis Patient, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of Reiki on dialysis symptoms (time frame: 2 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06772467, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.