- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04930341
The Effect of Self-Acupressure Application on Pain, Fatigue and Sleep Quality in Cancer Patients Receiving Chemotherapy
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Küçükçekmece
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Istanbul, Küçükçekmece, Turkey, 34303
- Istanbul Sabahattin Zaim University, Faculty of Health Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control group
Routine maintenance will be applied
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Experimental: Self-Acupressure
Each application to the acupressure points (H17, L14, ST36, SP6) will be done in 2 minutes and right and left)
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale
Time Frame: 1. week
|
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
Time Frame: 4. week
|
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
|
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The Piper Fatigue Scale
Time Frame: 1. week
|
The Piper Fatigue Scale is a 22-item, self-reported scale.
A total score of fatigue was recorded.
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1. week
|
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The Piper Fatigue Scale
Time Frame: 4. week
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The Piper Fatigue Scale is a 22-item, self-reported scale.
A total score of fatigue was recorded.
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4. week
|
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Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 1. week
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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"
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1. week
|
|
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 4. week
|
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
|
Collaborators and Investigators
Investigators
- Study Chair: Zülfünaz Özer, PhD, Istanbul Sabahattin Zaim University
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2308
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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