NCT04930341

Brief Summary

The aim of this study is to examine the effect of Self-Acupressure application on pain, fatigue and sleep quality in cancer patients receiving chemotherapy.

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 cancer

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable cancer

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

June 15, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2021

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

June 15, 2021

Last Update Submit

August 30, 2023

Conditions

Keywords

Self-AcupressurCancer patientsPainFatigueSleep quality

Outcome Measures

Primary Outcomes (6)

  • Visual Analog Scale

    The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm

    1. week

  • Visual Analog Scale

    The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm

    4. week

  • The Piper Fatigue Scale

    The Piper Fatigue Scale is a 22-item, self-reported scale. A total score of fatigue was recorded.

    1. week

  • The Piper Fatigue Scale

    The Piper Fatigue Scale is a 22-item, self-reported scale. A total score of fatigue was recorded.

    4. week

  • Pittsburgh Sleep Quality Index (PSQI)

    The PSQI is a valid and consistent survey comprising of 19 questions to assess quality and amount of sleep and the existence of a sleep disorder and its level in the previous month. The scale was adapted into the Turkish language by Agargün et al. (1996). The scale consists of seven components that assess patients subjective sleep quality, sleep delay, use of sleeping medication and disfunction in daily activities. Each item scores in the range 0-3 points and the total score of the seven components gives the total PSQI score. The total score has a value between 0-21 and a high total score demonstrates a poor quality of sleep. A total PSQI score which is ≤5 indicates "good sleep", and a score which is \>5 indicates "poor sleep"

    1. week

  • Pittsburgh Sleep Quality Index (PSQI)

    The PSQI is a valid and consistent survey comprising of 19 questions to assess quality and amount of sleep and the existence of a sleep disorder and its level in the previous month. The scale was adapted into the Turkish language by Agargün et al. (1996). The scale consists of seven components that assess patients subjective sleep quality, sleep delay, use of sleeping medication and disfunction in daily activities. Each item scores in the range 0-3 points and the total score of the seven components gives the total PSQI score. The total score has a value between 0-21 and a high total score demonstrates a poor quality of sleep. A total PSQI score which is ≤5 indicates "good sleep", and a score which is \>5 indicates "poor sleep"

    4. week

Study Arms (2)

Self-Acupressure

EXPERIMENTAL

Each application to the acupressure points (H17, L14, ST36, SP6) will be done in 2 minutes and right and left)

Other: Self-Acupressure

Control group

NO INTERVENTION

Routine maintenance will be applied

Interventions

Acupressure is a therapy method performed with an instrument or hand, fingertip, palm, elbow, knee, thumb relaxation and wrist bands on various points representing the waist organs in order to ensure the continuation and balance of the energy in our body.

Self-Acupressure

Eligibility Criteria

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

You may qualify if:

  • To have received at least one course of adjuvant chemotherapy before,
  • Not having a psychiatric diagnosis,
  • Being an early stage cancer patient
  • To be able to communicate adequately
  • Not having psychiatric problems
  • Volunteering to participate in research

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Sabahattin Zaim University, Faculty of Health Sciences

Istanbul, Küçükçekmece, 34303, Turkey (Türkiye)

Location

Related Publications (2)

  • He Y, Guo X, May BH, Zhang AL, Liu Y, Lu C, Mao JJ, Xue CC, Zhang H. Clinical Evidence for Association of Acupuncture and Acupressure With Improved Cancer Pain: A Systematic Review and Meta-Analysis. JAMA Oncol. 2020 Feb 1;6(2):271-278. doi: 10.1001/jamaoncol.2019.5233.

  • Dogan N, Tasci S. The Effects of Acupressure on Quality of Life and Dyspnea in Lung Cancer: A Randomized, Controlled Trial. Altern Ther Health Med. 2020 Jan;26(1):49-56.

MeSH Terms

Conditions

NeoplasmsPainFatigueSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Zülfünaz ÖZER, PhD

    Istanbul Sabahattin Zaim University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single (Participant) Self-Acupressure and control group
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study is an experimental study with pre-test and post-test control groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD., Assistant Prof

Study Record Dates

First Submitted

June 15, 2021

First Posted

June 18, 2021

Study Start

June 15, 2021

Primary Completion

August 27, 2021

Study Completion

October 27, 2021

Last Updated

August 31, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations