Self-Acupressure on Pain, Fatigue and Sleep Quality in Systemic Lupus Erythematosus

Sleep Disorder Clinical Trial

Official title:

The Effect of Self-Acupressure on Pain, Fatigue and Sleep Quality in Patients With Systemic Lupus Erythematosus: A Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05453422
• Other study ID #: 8990
• Status: Recruiting
• Phase: N/A
• Start date: July 4, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: July 2022
• Source: Istanbul Sabahattin Zaim University
• Contact: Zülfünaz Özer, PhD
• Phone: 05379537007
• Email: zulfinazozer[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to examine the effect of Self-acupressure application on pain, fatigue and sleep quality in sle patients.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Fatigue
• Lupus Erythematosus, Systemic
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Other:
• Self-Acupressure
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.

Locations

Country	Name	City	State
Turkey	Istanbul Sabahattin Zaim University, Faculty of Health Sciences	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Sabahattin Zaim University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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 ra — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At the end of Sessions 1 (each Session 2 days a week).
Primary	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.	At the end of Sessions 16 (each Session 2 days a week).
Primary	The Piper Fatigue Scale	The Piper Fatigue Scale is a 22-item, self-reported scale. A total score of fatigue was recorded.	At the end of Sessions 1 (each Session 2 days a week).
Primary	The Piper Fatigue Scale	The Piper Fatigue Scale is a 22-item, self-reported scale. A total score of fatigue was recorded.	At the end of Sessions 16 (each Session 2 days a week).
Primary	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.	At the end of Sessions 1 (each Session 2 days a week).
Primary	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.	At the end of Sessions 16 (each Session 2 days a week).