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The Effect of Acupressure and Reiki on Pain and Fatigue Levels

Primary Purpose

Acupressure, Cancer Pain, Fatigue

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Acupressure intervention

Reiki intervention

About this trial

This is an interventional treatment trial for Acupressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

having a diagnosis of third or fourth-stage cancer,
being aged 18 years or older,
having had pain for at least one month in connection with cancer treatment or the symptoms of the disease,
using NSAII or non-opioid analgesics,
having a status of 3 or more on the Numeric Pain Rating Scale (NPRS),
having a score of 0-3 on the ECOG-PS scale

Exclusion Criteria:

having a diagnosis of first or second-stage cancer,
being aged less than 18 years,
having bone or brain metastasis,
using opioid analgesics,
having a status of less than 3 on the NPRS,
having a status of between 4 and 5 on the ECOG-PS scale

Sites / Locations

Hediye Utli

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Acupressure

Reiki

Control

Arm Description

Acupressure intervention

Reiki intervention

No intervention.

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale

A score of 0 indicates no pain, 1-3 slight pain, 4-6 moderate pain, and 7-10 severe pain .

Brief Fatigue Inventory

It is scored between 0 and 10.

Secondary Outcome Measures

Full Information

NCT ID

NCT05473845

First Posted

July 21, 2022

Last Updated

July 22, 2022

Sponsor

Mardin Artuklu University

1. Study Identification

Unique Protocol Identification Number

NCT05473845

Brief Title

The Effect of Acupressure and Reiki on Pain and Fatigue Levels

Official Title

The Effect of Acupressure and Reiki on Pain and Fatigue Levels in Cancer Patients Receiving Palliative Care

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

February 11, 2022 (Actual)

Primary Completion Date

July 21, 2022 (Actual)

Study Completion Date

July 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mardin Artuklu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This research was conducted with the aim of determining the effect of levels of pain and fatigue of acupressure and Reiki application on cancer patients receiving palliative care. The research was a single-blind, repeated measures, randomized controlled study. Research data were collected between February and July 2022. The research sample consisted of acupressure and Reiki application groups and a control group with 52 patients in each group, a total of 156 patients. Data was collected by means of a Patient Description Form, an Analgesic Follow-up Form, the Eastern Cooperative Oncology Group Performance Status Scale, the Numeric Pain Rating Scale, and the Brief Fatigue Inventory.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acupressure, Cancer Pain, Fatigue

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

156 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acupressure

Arm Type

Experimental

Arm Description

Acupressure intervention

Arm Title

Reiki

Arm Type

Experimental

Arm Description

Reiki intervention

Arm Title

Control

Arm Type

No Intervention

Arm Description

No intervention.

Intervention Type

Procedure

Intervention Name(s)

Acupressure intervention

Intervention Description

Acupressure

Intervention Type

Procedure

Intervention Name(s)

Reiki intervention

Intervention Description

Reiki

Primary Outcome Measure Information:

Title

Numeric Pain Rating Scale

Description

A score of 0 indicates no pain, 1-3 slight pain, 4-6 moderate pain, and 7-10 severe pain .

Time Frame

on the second day of the starting week

Title

Brief Fatigue Inventory

Description

It is scored between 0 and 10.

Time Frame

on the second day of the starting week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: having a diagnosis of third or fourth-stage cancer, being aged 18 years or older, having had pain for at least one month in connection with cancer treatment or the symptoms of the disease, using NSAII or non-opioid analgesics, having a status of 3 or more on the Numeric Pain Rating Scale (NPRS), having a score of 0-3 on the ECOG-PS scale Exclusion Criteria: having a diagnosis of first or second-stage cancer, being aged less than 18 years, having bone or brain metastasis, using opioid analgesics, having a status of less than 3 on the NPRS, having a status of between 4 and 5 on the ECOG-PS scale

Facility Information:

Facility Name

Hediye Utli

City

Mardin

ZIP/Postal Code

47200

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

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The Effect of Acupressure and Reiki on Pain and Fatigue Levels

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