ReikiReiki AppNCT06902259
The Effect of Breath Exercıse and Reıkı Applıcatıon
A study of Reiki and Breath Exercise, run by Aslıhan ÖZTÜRK ÇETİN at 1 site in Turkey (Türkiye).
Trial summary
: This randomised controlled trial was conducted to investigate the effects of breathing exercise and reiki on fatigue and nausea and vomiting symptoms in oncology patients. Data were collected between 1 December 2023 and 30 May 2024, just before the patients started chemotherapy treatment, using data collection forms… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Reiki, Breath Exercise, Tıredness and Nausea and Vomiting Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 1 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
- Patients who volunteered to participate in the study, were diagnosed with cancer, had symptoms of nausea-vomiting and fatigue, were literate, could communicate, did not have a diagnosis of mental or psychiatric illness, were not hearing or visually impaired, were 18 years of age or older, and were not receiving antiemetic treatment.
Who cannot join
- Patients with any other disease related to the gastrointestinal system, any other disease or condition that would prevent them from performing the exercises to be performed for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Breath Exercıse and Reıkı Applıcatıon on Tıredness and Nausea and Vomiting Management in Oncology Patıents; Randomısed Controlled Study
: This randomised controlled trial was conducted to investigate the effects of breathing exercise and reiki on fatigue and nausea and vomiting symptoms in oncology patients. Data were collected between 1 December 2023 and 30 May 2024, just before the patients started chemotherapy treatment, using data collection forms with a face-to-face interview method of approximately 30 minutes. Since it was thought that there might be case losses during the study, it was decided to take 20 patients for both groups.
Read the detailed description
The study was conducted with cancer patients receiving treatment in the outpatient chemotherapy unit of a university hospital between 1 December 2024 and 30 May 2024.The population of the study was 600 cancer patients receiving chemotherapy in the Outpatient Chemotherapy Unit of a university hospital. The sample consisted of patients who applied to the Medical Oncology Outpatient Clinic for treatment between 1 December 2023 and 30 May 2024, who accepted to participate in the study and met the inclusion criteria. Power analysis was performed to determine the sample size. The power of the study was calculated with the G Power 3.1 programme. Accordingly, it was determined that there should be at least 18 patients in each group. Since it was thought that there might be case losses during the study, it was decided to take 20 patients for both groups. Sixty patients, including 20 patients in each group, who met the inclusion criteria were identified. The details of the study were explained to the patients and their consent was obtained. In order to minimise selection bias, a simple random sampling method, the random numbers table, was used and patients were assigned to groups as 20 reiki group, 20 breathing exercise group and 20 control group.Patients who volunteered to participate in the study, were diagnosed with cancer, had symptoms of nausea-vomiting and fatigue, were literate, could communicate, did not have a diagnosis of mental or psychiatric illness, were not hearing or visually impaired, were 18 years of age or older, and were not receiving antiemetic treatment.
Exclusion criteria: Patients with any other disease related to the gastrointestinal system, any other disease or condition that would prevent them from performing the exercises to be performed for the study.
Before starting the study, approval was obtained from the Bakırçay University Non-Interventional Clinical Research Ethics Committee of a state university (25.10.2023/Decision no: 1259). Institutional permission was obtained from the hospital where the study was conducted. In order to use the Hirai Cancer Fatigue Scale in the study, permission to use the scale was obtained from the author via e-mail. Verbal and written informed consent was obtained from all participants. The study was conducted according to the principles of the Helsinki Declaration of Human Rights.The data obtained in the study were analysed using SPSS (Statistical Package for Social Sciences) for Windows 22.0 software. Number, percentage, mean, standard deviation were used as descriptive statistical methods in the evaluation of the data. Differences between the rates of categorical variables in independent groups were analysed by Chi-Square tests. Kurtosis and Skewness values were analysed to determine whether the research variables showed normal distribution.
In the related literature, the results of kurtosis and skewness values of the variables between +1.5 and -1.5, +2.0 and -2.0 are accepted as normal distribution. Since it was determined that the variables were normally distributed, parametric methods were used to analyse the data [15,16]. One way Anova test was used to compare quantitative continuous data between groups. Scheffe test was used as a complementary post-hoc analysis to determine the differences after the Anova test. Repeated measures ANOVA test and complementary Bonferroni test were used for the comparison of intra-group measurements.
- Being tested
- randomised controlled trial
- Keywords
- reiki, symptom management, breath exercise, oncology patients
- Medical subject headings
- Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
randomised controlled trialOther
Breathing exercise group: Sixty patients, including 20 patients in each group, who met the inclusion criteria were identified. The details of the study were explained to the patients and their consent was obtained. In order to minimise selection bias, a simple random sampling method, the random numbers table, was used and patients were assigned to groups as 20 reiki group, 20 breathing exercise group and 20 control group.
Reiki group: Sixty patients, including 20 patients in each group, who met the inclusion criteria were identified. The details of the study were explained to the patients and their consent was obtained. In order to minimise selection bias, a simple random sampling method, the random numbers table, was used and patients were assigned to groups as 20 reiki group, 20 breathing exercise group and 20 control group.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Sixty patients, including 20 patients in each group, who met the inclusion criteria were identified. The details of the study were explained to the patients and their consent was obtained. In order to minimise selection bias, a simple random sampling method, the random numbers table, was used and patients were assigned to groups as 20 reiki group, 20 breathing exercise group and 20 control group. |
| Breathing exercise group | Other | Sixty patients, including 20 patients in each group, who met the inclusion criteria were identified. The details of the study were explained to the patients and their consent was obtained. In order to minimise selection bias, a simple random sampling method, the random numbers table, was used and patients were assigned to groups as 20 reiki group, 20 breathing exercise group and 20 control group. Receives: Other: randomised controlled trial |
| Reiki group | Other | Sixty patients, including 20 patients in each group, who met the inclusion criteria were identified. The details of the study were explained to the patients and their consent was obtained. In order to minimise selection bias, a simple random sampling method, the random numbers table, was used and patients were assigned to groups as 20 reiki group, 20 breathing exercise group and 20 control group. Receives: Other: randomised controlled trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual Introductory Information Form
The Individual Descriptive Information Form was prepared by the researchers in line with the literature information and consists of questions such as socio-demographic characteristics such as age, marital status, chronic diseases, disease history, and type, stage, metastasis status, metastasis site, treatment status, nausea and vomiting [5-9].
Measured: 4 months
Secondary outcomes (1)
Hirai Cancer Fatigue Scale
The scale developed by Kazue Hirai et al. in 2015 and adapted into Turkish by Mencel in 2021 consists of 15 items. The scale measures fatigue in cancer patients and is 5-point Likert type. Each item of the scale is evaluated as 1 'not at all', 2 'very little', 3 'a little', 4 'a lot', 5 'very much'. There are 3 sub-dimensions: physical - mental sub-dimension, activity-related sensitivity, cognitive sensitivity. Items 1-6 in the scale include physical-mental sub-dimension, items 7-12 include activity-related sensitivity sub-dimension and items 12-15 include cognitive sensitivity sub-dimension. The scale has no cut-off point. The minimum value of the scale is 15 and the maximum value is 75. High scores on the scale indicate increased fatigue and low scores indicate decreased fatigue.14 The Cronbach Alpha value of the original scale was found to be 0.943. The Cronbach Alpha value in this study was found to be 0.896.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start1 Mar 2024
- Primary completion1 Jul 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ReikiStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aslıhan ÖZTÜRK ÇETİN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aslıhan ÖZTÜRK ÇETİN, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902259
- Sponsor's protocol ID
- Bakircay Unversity
- Acronym
- Reiki App
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breath Exercıse and Reıkı Applıcatıon on Tıredness and Nausea and Vomiting Management in Oncology Patıents; Randomısed Controlled Study
- ClinicalTrials.gov ID
- NCT06902259
- Acronym / sponsor ID
- Reiki App / Bakircay Unversity
- Keywords
- reiki, symptom management, breath exercise, oncology patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aslıhan ÖZTÜRK ÇETİNUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 30 Mar 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.
: This randomised controlled trial was conducted to investigate the effects of breathing exercise and reiki on fatigue and nausea and vomiting symptoms in oncology patients. Data were collected between 1 December 2023 and 30 May 2024, just before the patients started chemotherapy treatment, using data collection forms with a face-to-face interview method of approximately 30 minutes. Since it was thought that there might be case losses during the study, it was decided to take 20 patients for both groups.
Detailed description
The study was conducted with cancer patients receiving treatment in the outpatient chemotherapy unit of a university hospital between 1 December 2024 and 30 May 2024.The population of the study was 600 cancer patients receiving chemotherapy in the Outpatient Chemotherapy Unit of a university hospital. The sample consisted of patients who applied to the Medical Oncology Outpatient Clinic for treatment between 1 December 2023 and 30 May 2024, who accepted to participate in the study and met the inclusion criteria. Power analysis was performed to determine the sample size. The power of the study was calculated with the G Power 3.1 programme. Accordingly, it was determined that there should be at least 18 patients in each group. Since it was thought that there might be case losses during the study, it was decided to take 20 patients for both groups. Sixty patients, including 20 patients in each group, who met the inclusion criteria were identified. The details of the study were explained to the patients and their consent was obtained. In order to minimise selection bias, a simple random sampling method, the random numbers table, was used and patients were assigned to groups as 20 reiki group, 20 breathing exercise group and 20 control group.Patients who volunteered to participate in the study, were diagnosed with cancer, had symptoms of nausea-vomiting and fatigue, were literate, could communicate, did not have a diagnosis of mental or psychiatric illness, were not hearing or visually impaired, were 18 years of age or older, and were not receiving antiemetic treatment.
Exclusion criteria: Patients with any other disease related to the gastrointestinal system, any other disease or condition that would prevent them from performing the exercises to be performed for the study.
Before starting the study, approval was obtained from the Bakırçay University Non-Interventional Clinical Research Ethics Committee of a state university (25.10.2023/Decision no: 1259). Institutional permission was obtained from the hospital where the study was conducted. In order to use the Hirai Cancer Fatigue Scale in the study, permission to use the scale was obtained from the author via e-mail. Verbal and written informed consent was obtained from all participants. The study was conducted according to the principles of the Helsinki Declaration of Human Rights.The data obtained in the study were analysed using SPSS (Statistical Package for Social Sciences) for Windows 22.0 software. Number, percentage, mean, standard deviation were used as descriptive statistical methods in the evaluation of the data. Differences between the rates of categorical variables in independent groups were analysed by Chi-Square tests. Kurtosis and Skewness values were analysed to determine whether the research variables showed normal distribution.
In the related literature, the results of kurtosis and skewness values of the variables between +1.5 and -1.5, +2.0 and -2.0 are accepted as normal distribution. Since it was determined that the variables were normally distributed, parametric methods were used to analyse the data [15,16]. One way Anova test was used to compare quantitative continuous data between groups. Scheffe test was used as a complementary post-hoc analysis to determine the differences after the Anova test. Repeated measures ANOVA test and complementary Bonferroni test were used for the comparison of intra-group measurements.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Sixty patients, including 20 patients in each group, who met the inclusion criteria were identified. The details of the study were explained to the patients and their consent was obtained. In order to minimise selection bias, a simple random sampling method, the random numbers table, was used and patients were assigned to groups as 20 reiki group, 20 breathing exercise group and 20 control group. |
| Breathing exercise group | Other | Other: randomised controlled trialSixty patients, including 20 patients in each group, who met the inclusion criteria were identified. The details of the study were explained to the patients and their consent was obtained. In order to minimise selection bias, a simple random sampling method, the random numbers table, was used and patients were assigned to groups as 20 reiki group, 20 breathing exercise group and 20 control group. |
| Reiki group | Other | Other: randomised controlled trialSixty patients, including 20 patients in each group, who met the inclusion criteria were identified. The details of the study were explained to the patients and their consent was obtained. In order to minimise selection bias, a simple random sampling method, the random numbers table, was used and patients were assigned to groups as 20 reiki group, 20 breathing exercise group and 20 control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who volunteered to participate in the study, were diagnosed with cancer, had symptoms of nausea-vomiting and fatigue, were literate, could communicate, did not have a diagnosis of mental or psychiatric illness, were not hearing or visually impaired, were 18 years of age or older, and were not receiving antiemetic treatment.
Key exclusion criteria (1 listed)
- Patients with any other disease related to the gastrointestinal system, any other disease or condition that would prevent them from performing the exercises to be performed for the study.
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 |
|---|---|---|
| randomised controlled trialBreathing exercise group: Sixty patients, including 20 patients in each group, who met the inclusion criteria were identified. The details of the study were explained to the patients and their consent was obtained. In order to minimise selection bias, a simple random sampling method, the random numbers table, was used and patients were assigned to groups as 20 reiki group, 20 breathing exercise group and 20 control group. Reiki group: Sixty patients, including 20 patients in each group, who met the inclusion criteria were identified. The details of the study were explained to the patients and their consent was obtained. In order to minimise selection bias, a simple random sampling method, the random numbers table, was used and patients were assigned to groups as 20 reiki group, 20 breathing exercise group and 20 control group. | Other | Breathing exercise group, Reiki group |
Primary outcome
Individual Introductory Information Form
Time frame: 4 months
The Individual Descriptive Information Form was prepared by the researchers in line with the literature information and consists of questions such as socio-demographic characteristics such as age, marital status, chronic diseases, disease history, and type, stage, metastasis status, metastasis site, treatment status, nausea and vomiting [5-9].
1 secondary outcome
Hirai Cancer Fatigue Scale
Time frame: 4 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 30 Mar 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Reiki and Breath Exercise, run by Aslıhan ÖZTÜRK ÇETİN 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 1 inclusion and 1 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 30 Mar 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?
Individual Introductory Information Form (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2025.