Tiredness and Nausea and Vomiting Management in Oncology Patients

NCT07069023 | Completed DMC

• 2 other identifiers: BCU1259Reıkı and Oncology Patients
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This randomised controlled trial will investigate the effects of breathing exercises and Reiki on fatigue and nausea-vomiting symptoms in oncology patients. Data will be collected through face-to-face interviews using structured forms before the start of chemotherapy. To account for possible losses, 20 patients will be included in each intervention group.

Conditions

Cancer; Fatigue; Nausea

Keywords

Breath exercise; reiki application; tiredness; nausea; vomiting

Outcome Measures

Primary Outcomes (2)

• Individual Introductory Information Form

  It was 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

  6 WEEKS

• Hirai Cancer Fatigue Scale

  The scale measures fatigue in cancer patients and is 5-point Likert type. 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.The Cronbach Alpha value of the original scale was found to be 0.943.

  6 WEEKS

Study Arms (2)

reiki group

ACTIVE COMPARATOR

Oncology patients with nausea, vomiting and fatigue received reiki throughout the treatment.

Other: breathing exercise group; Other: reiki group

breathing exercise group

ACTIVE COMPARATOR

Oncology patients with nausea, vomiting and fatigue were given breathing exercises throughout the treatment.

Other: breathing exercise group; Other: reiki group

Interventions

breathing exercise group OTHER

Oncology patients with nausea, vomiting and fatigue were given breathing exercises throughout the treatment.

Also known as: control group

breathing exercise group; reiki group

reiki group OTHER

Oncology patients with nausea, vomiting and fatigue received reiki throughout the treatment.

breathing exercise group; reiki group

Eligibility Criteria

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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Sağlık Bilimleri Üniversitesi

Istanbul, 34255, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neoplasms; Fatigue; Nausea; Vomiting

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Gamze Temiz

  Saglik Bilimleri Universitesi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study employed a three-group experimental design involving a breathing exercise group, a Reiki group, and a control group. Participants in the intervention groups received sessions twice a week for six weeks, while the control group received no intervention. Data were collected at three points: pre-test (week 1), mid-test (week 3), and post-test (week 6), using validated instruments. These assessments aimed to measure changes over time and compare group differences. Ethical approval was obtained, and informed consent was secured from all participants.

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: July 16, 2025
• Study Start: December 1, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: July 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)