Back to resultsSelf-Acupressure on Pain, Fatigue and Sleep Quality in Systemic Lupus Erythematosus
Primary Purpose
Sleep Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Self-Acupressure
Sponsored by
About this trial
This is an interventional supportive care trial for Sleep Disorder focused on measuring Fatigue, Pain, Sleep quality, Systematic lupus erythemasus
Eligibility Criteria
Inclusion Criteria:
- Being over the age of 18,
- Not using acupressure and similar integrative treatment methods,
- Not having a verbal communication disability (hearing and speaking),
- Not having a diagnosed psychiatric disorder,
- Not having a cognitive problem,
- Getting a score between 1-10 on the Piper Fatigue Scale,
- Getting a score between 1-10 on the VAS pain scale
- Agree to participate in the research.
- Not being in the active period of SLE (exacerbation in the last 3 months or not using steroids for 3 months)
- Not using other complementary and integrated health practices in the treatment process
Exclusion Criteria:
-
Sites / Locations
- Istanbul Sabahattin Zaim University, Faculty of Health SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Self-Acupressure
Control group
Arm Description
Each application to the acupressure points (H17, L14, ST36, SP6) will be done in 2 minutes and right and left)
Routine maintenance will be applied.
Outcomes
Primary Outcome Measures
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.
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.
The Piper Fatigue Scale
The Piper Fatigue Scale is a 22-item, self-reported scale. A total score of fatigue was recorded.
The Piper Fatigue Scale
The Piper Fatigue Scale is a 22-item, self-reported scale. A total score of fatigue was recorded.
The Richards-Campbell Sleep Questionnaire
This brief five-item questionnaire was used to evaluate perceived sleep depth, sleep latency (time to fall asleep), number of awakenings, efficiency (percentage of time awake), and sleep quality. It also includes a sixth item evaluating perceived night-time noise. Each item is evaluated on a scale of 0-100 with a visual analogue scale technique. A score of 0-25 indicates very poor quality sleep, whereas a score of 76-100 indicates very good sleep quality.
The Richards-Campbell Sleep Questionnaire
This brief five-item questionnaire was used to evaluate perceived sleep depth, sleep latency (time to fall asleep), number of awakenings, efficiency (percentage of time awake), and sleep quality. It also includes a sixth item evaluating perceived night-time noise. Each item is evaluated on a scale of 0-100 with a visual analogue scale technique. A score of 0-25 indicates very poor quality sleep, whereas a score of 76-100 indicates very good sleep quality.
Secondary Outcome Measures
Full Information
NCT ID
NCT05453422
First Posted
July 6, 2022
Last Updated
July 10, 2022
Sponsor
Istanbul Sabahattin Zaim University
1. Study Identification
Unique Protocol Identification Number
NCT05453422
Brief Title
Self-Acupressure on Pain, Fatigue and Sleep Quality in Systemic Lupus Erythematosus
Official Title
The Effect of Self-Acupressure on Pain, Fatigue and Sleep Quality in Patients With Systemic Lupus Erythematosus: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 4, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Sabahattin Zaim University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this study is to examine the effect of Self-acupressure application on pain, fatigue and sleep quality in sle patients.
Detailed Description
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 our body in order to ensure the continuation and balance of the energy in our body.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorder
Keywords
Fatigue, Pain, Sleep quality, Systematic lupus erythemasus
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is an experimental study with pre-test and post-test control groups
Masking
Participant
Masking Description
Self-Acupressure and control group
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Self-Acupressure
Arm Type
Experimental
Arm Description
Each application to the acupressure points (H17, L14, ST36, SP6) will be done in 2 minutes and right and left)
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Routine maintenance will be applied.
Intervention Type
Other
Intervention Name(s)
Self-Acupressure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
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.
Time Frame
At the end of Sessions 1 (each Session 2 days a week).
Title
Visual Analog Scale
Description
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.
Time Frame
At the end of Sessions 16 (each Session 2 days a week).
Title
The Piper Fatigue Scale
Description
The Piper Fatigue Scale is a 22-item, self-reported scale. A total score of fatigue was recorded.
Time Frame
At the end of Sessions 1 (each Session 2 days a week).
Title
The Piper Fatigue Scale
Description
The Piper Fatigue Scale is a 22-item, self-reported scale. A total score of fatigue was recorded.
Time Frame
At the end of Sessions 16 (each Session 2 days a week).
Title
The Richards-Campbell Sleep Questionnaire
Description
This brief five-item questionnaire was used to evaluate perceived sleep depth, sleep latency (time to fall asleep), number of awakenings, efficiency (percentage of time awake), and sleep quality. It also includes a sixth item evaluating perceived night-time noise. Each item is evaluated on a scale of 0-100 with a visual analogue scale technique. A score of 0-25 indicates very poor quality sleep, whereas a score of 76-100 indicates very good sleep quality.
Time Frame
At the end of Sessions 1 (each Session 2 days a week).
Title
The Richards-Campbell Sleep Questionnaire
Description
This brief five-item questionnaire was used to evaluate perceived sleep depth, sleep latency (time to fall asleep), number of awakenings, efficiency (percentage of time awake), and sleep quality. It also includes a sixth item evaluating perceived night-time noise. Each item is evaluated on a scale of 0-100 with a visual analogue scale technique. A score of 0-25 indicates very poor quality sleep, whereas a score of 76-100 indicates very good sleep quality.
Time Frame
At the end of Sessions 16 (each Session 2 days a week).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Being over the age of 18,
Not using acupressure and similar integrative treatment methods,
Not having a verbal communication disability (hearing and speaking),
Not having a diagnosed psychiatric disorder,
Not having a cognitive problem,
Getting a score between 1-10 on the Piper Fatigue Scale,
Getting a score between 1-10 on the VAS pain scale
Agree to participate in the research.
Not being in the active period of SLE (exacerbation in the last 3 months or not using steroids for 3 months)
Not using other complementary and integrated health practices in the treatment process
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zülfünaz Özer, PhD
Phone
05379537007
Email
zulfinazozer@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zülfünaz Özer, PhD
Organizational Affiliation
Istanbul Sabahattin Zaim University
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul Sabahattin Zaim University, Faculty of Health Sciences
City
Istanbul
ZIP/Postal Code
340340
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zülfünaz Özer, PhD
Phone
05379537007
Email
zulfinazozer@gmail.com
First Name & Middle Initial & Last Name & Degree
Gülcan Bahçecioğlu Turan, PhD
First Name & Middle Initial & Last Name & Degree
Nurdan Şahin
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33144299
Citation
Aranow C, Atish-Fregoso Y, Lesser M, Mackay M, Anderson E, Chavan S, Zanos TP, Datta-Chaudhuri T, Bouton C, Tracey KJ, Diamond B. Transcutaneous auricular vagus nerve stimulation reduces pain and fatigue in patients with systemic lupus erythematosus: a randomised, double-blind, sham-controlled pilot trial. Ann Rheum Dis. 2021 Feb;80(2):203-208. doi: 10.1136/annrheumdis-2020-217872. Epub 2020 Nov 3. Erratum In: Ann Rheum Dis. 2021 May;80(5):e82.
Results Reference
result
PubMed Identifier
18306446
Citation
Wang T, Zhang Q, Xue X, Yeung A. A systematic review of acupuncture and moxibustion treatment for chronic fatigue syndrome in China. Am J Chin Med. 2008;36(1):1-24. doi: 10.1142/S0192415X08005540.
Results Reference
result
Learn more about this trial
Self-Acupressure on Pain, Fatigue and Sleep Quality in Systemic Lupus Erythematosus
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