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

Sponsor

Istanbul Sabahattin Zaim University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05453422

Collaborator

(none)

Enrollment

Location

Arms

2.9

Anticipated Duration (Months)

24.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Disorder	Other: Self-Acupressure	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This study is an experimental study with pre-test and post-test control groupsThis study is an experimental study with pre-test and post-test control groups

Masking:

Single (Participant)

Masking Description:

Self-Acupressure and control group

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jul 4, 2022

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Self-Acupressure Each application to the acupressure points (H17, L14, ST36, SP6) will be done in 2 minutes and right and left)	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.
No Intervention: Control group Routine maintenance will be applied.

Arm

Intervention/Treatment

Experimental: Self-Acupressure

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

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.

No Intervention: Control group

Routine maintenance will be applied.

Outcome Measures

Primary Outcome Measures

Visual Analog Scale [At the end of Sessions 1 (each Session 2 days a 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.
Visual Analog Scale [At the end of Sessions 16 (each Session 2 days a 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.
The Piper Fatigue Scale [At the end of Sessions 1 (each Session 2 days a week).]
The Piper Fatigue Scale is a 22-item, self-reported scale. A total score of fatigue was recorded.
The Piper Fatigue Scale [At the end of Sessions 16 (each Session 2 days a week).]
The Piper Fatigue Scale is a 22-item, self-reported scale. A total score of fatigue was recorded.
The Richards-Campbell Sleep Questionnaire [At the end of Sessions 1 (each Session 2 days a week).]
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 [At the end of Sessions 16 (each Session 2 days a week).]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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