NCT05473845

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

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

February 11, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 26, 2022

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

5 months

First QC Date

July 21, 2022

Last Update Submit

July 22, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Numeric Pain Rating Scale

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

    on the second day of the starting week

  • Brief Fatigue Inventory

    It is scored between 0 and 10.

    on the second day of the starting week

Study Arms (3)

Acupressure

EXPERIMENTAL

Acupressure intervention

Procedure: Acupressure intervention

Reiki

EXPERIMENTAL

Reiki intervention

Procedure: Reiki intervention

Control

NO INTERVENTION

No intervention.

Interventions

Acupressure

Acupressure

Reiki

Reiki

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hediye Utli

Mardin, 47200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cancer PainFatigue

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, MSc, RN, Assistant Professor

Study Record Dates

First Submitted

July 21, 2022

First Posted

July 26, 2022

Study Start

February 11, 2022

Primary Completion

July 21, 2022

Study Completion

July 21, 2022

Last Updated

July 26, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations