NCT06902259

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

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

March 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2025

Completed
Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

4 months

First QC Date

March 24, 2025

Last Update Submit

March 24, 2025

Conditions

Keywords

reikisymptom managementbreath exerciseoncology patients

Outcome Measures

Primary Outcomes (1)

  • 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 \[5-9\].

    4 months

Secondary Outcomes (1)

  • Hirai Cancer Fatigue Scale

    4 months

Study Arms (3)

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.

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.

Other: randomised controlled trial

Interventions

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.

Breathing exercise groupReiki group

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Bakircay University

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Nausea

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Res. Ass. RN, MSc, PhD

Study Record Dates

First Submitted

March 24, 2025

First Posted

March 30, 2025

Study Start

March 1, 2024

Primary Completion

July 1, 2024

Study Completion

December 1, 2024

Last Updated

March 30, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations