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The Effect of Self Acupressure Application on Pain, Fatigue and Sleep Quality in Multiple Myeloma Patients

Primary Purpose

Self Acupressure, Sleep, Fatigue

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Self acupressure
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Self Acupressure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Having a scale score of >5 on the Piper Fatigue Scale Having a score of >5 on the Pittsburgh Sleep Quality Scale Pain severity is 5 points or higher according to the Visual Analog Scale Exclusion criteria; Using acupressure and similar integrative treatment methods, Having a verbal communication disability (hearing and speaking), Having a diagnosed psychiatric disorder,

Sites / Locations

  • Gülcan B TuranRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental:

Control

Arm Description

Self acupressure

Routine maintenance will be applied.

Outcomes

Primary Outcome Measures

Pitssburg Sleep Quality Index
It was developed by Buysse et al. (1989) (34). The scale is a safe and consistent questionnaire that evaluates the amount of sleep, sleep quality, presence and severity of sleep disorders in individuals in the last month. It was adapted into Turkish by Ağargün et al. (1996) (35). There are seven components in PUKI. These components are subjective sleep quality (component 1), sleep latency (component 2), sleep duration (component 3), habitual sleep efficiency (component 4), sleep disturbance (component 5), sleep medication use (component 6) and daytime dysfunction. (component 7). The evaluation score of each item is between 0-3. The total score obtained varies between 0-21. The higher the score, the worse the sleep quality.
Piper Fatigue Scale
The Piper Fatigue Scale was developed in 1987 by Piper et al. It was developed by.The Turkish validity and reliability study of the scale was conducted by Can in 2001 (37). The scale evaluates the individual's subjective perception of fatigue in four sub-dimensions. These; behavior/violence sub-dimension evaluating the effect and severity of fatigue on activities of daily living (ADLs (6 items; 2-7); affect sub-dimension, which includes the emotional meaning attributed to fatigue (5 items; 8-12); it is the sensory sub-dimension (5 items; 13-17) that reflects the mental, physical and emotional symptoms of fatigue, and the cognitive/spiritual sub-dimension that reflects the effect of fatigue on cognitive functions and mental state (6 items; 18-23). As a result of the average score; 0 points are interpreted as no fatigue, 1-3 points as mild fatigue, 4-6 points as moderate fatigue, 7-10 points as severe fatigue.
Visual Analog Scale
Patients are asked to show the intensity of pain on a 10 cm long vertical or horizontal line during activity or rest. It has numbered shapes ranging from 1-10. The line has 0 at the beginning and 10 at the end. 10 means unbearable pain, 0 means no pain. The VAS scale is frequently used in the evaluation of pain severity. While the patient marks the pain he/she has felt on this line, each point marked is measured in cm.

Secondary Outcome Measures

Full Information

First Posted
April 24, 2023
Last Updated
June 6, 2023
Sponsor
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT05842265
Brief Title
The Effect of Self Acupressure Application on Pain, Fatigue and Sleep Quality in Multiple Myeloma Patients
Official Title
The Effect of Self Acupressure Application on Pain, Fatigue and Sleep Quality in Multiple Myeloma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 24, 2023 (Actual)
Primary Completion Date
June 20, 2023 (Anticipated)
Study Completion Date
August 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Multiple Myeloma occurs with damaging bone lesion, hypercalcemia, anemia and renal failure as a result of secretion of monoclonal protein in serum and/or urea and accumulation of plasma cells. The most common symptoms at the time of diagnosis are; fatigue, insomnia, bone pain and recurrent infections. In multiple myeloma patients, pain, fatigue and sleep problems are conditions that significantly affect the daily life activities of the individual and require planned nursing interventions for the solution. In this challenging process, a holistic approach should be adopted while planning the care practices of the patients, and non-pharmacological practices should be planned, which will enable the patient to perform the activities of daily life with minimum energy and maximum function. Acupressure, one of the non-pharmacological applications, is a complementary medicine method that ensures the proper functioning of the energy channels by applying pressure to the points on the energy-carrying meridians (these points are the same as acupuncture points) with fingers, palms or wrist bands without using needles, unlike acupuncture. In the literature, it is stated that acupressure is a pain-relieving, relaxing analgesic and immune system-strengthening supportive method rather than its therapeutic effect, and it relieves insomnia and fatigue and relieves the person. In addition, within the scope of the harmonization model; By teaching acupressure to patients by nurses, patients can be actively involved in their own symptom management. Therefore, this study was planned to evaluate the effect of self-acupressure applied to patients with multiple myeloma on pain, fatigue and sleep quality. The research will be conducted as a randomized, experimental study with a pretest-posttest control group. The sample of the study will consist of 52 Multiple Myeloma patients, 26 experimental and 26 control groups, who met the research criteria and accepted the study, between August 2022 and January 2023, in Hematology Clinic and Polyclinic of Fırat University Hospital. Patients in the experimental group will be asked to perform self-acupressure by showing and teaching the LI4, HT 7, ST36 and SP6 acupressure points by the researcher. Depending on the preparation and compression time on these 4 points, the patients will be asked to perform a total of 16 sessions for 4 weeks, for a total of 18 minutes, 2 days a week in the morning and afternoon. The 1st measurement will be obtained by applying the Patient Information Form, Visual Analog Scale "Pitssburg Sleep Quality Index (PUKI)" and Piper Fatigue Scale" to the patients in the experimental group at the pre-test stage before the application. After 4 weeks, the Pitssburg Sleep Quality Index (PUKI) and The second measurement will be obtained by applying the "Piper Fatigue Scale" again. No application will be made to the patients in the control group. In the pre-test phase, the 1st measurement will be obtained by applying only the Patient Information Form, Visual Analog Scale, Pitssburg Sleep Quality Index (PUKI) and Piper Fatigue Scale. After 4 weeks, in the post-test phase, the second measurement will be obtained by re-applying the other forms except the Patient Information Form. The data will be analyzed using the SPSS 23 program. Shapiro Wilk test, t test, Mann-Whitney U test, Wilcoxon test and Chi-square analysis will be used in the analysis of the data.
Detailed Description
Multiple myeloma (MM) is a disease characterized by monoclonal neoplastic proliferation of immunoglobulin-producing plasma cells (1). Plasma cells proliferate in the bone marrow and cause extensive damage to the skeletal system, often with osteolytic lesions, osteopenia, and/or pathological fractures. Anemia is a malignant disease characterized by the presence of monoclonal protein in serum and urine, hypercalcemia, and renal failure (1). Multiple Myeloma is a disease of advanced age. The mean age at diagnosis of the patients is 66. It constitutes 1% of all malignancies and 10% of hematological malignancies (2). Although its etiology is not known exactly, it is thought that obesity, smoking, diet, radiation, immune system and environmental factors may be responsible (3). Plasma cells develop from B lymphocytes (4). Bone marrow microenvironment is important in the development of Multiple Myeloma. Advanced stage memory B cell/plasmablast, which has provided the isotypic change of Immune globulin (Ig) in the germinal center, is the premyeloma cell in which the oncogenic effect begins. It then settles in the bone marrow a second oncogenic effect occurs in the cell (5). Multiple Myeloma is a disease with a wide clinical spectrum. Symptoms and signs related to anemia, radicular back and low back pain due to pathological vertebral fractures, bone pain due to osteolytic lesions, pathological fractures, peripheral polyneuropathy, renal failure, hypercalcemia, hyperviscosity syndrome, thrombosis and bleeding tendency, infection can be seen in patients (6). It is evaluated whether the patient is a candidate for autologous stem cell transplantation (OKHN) in the treatment of Multiple Myeloma. In young patients with MM, high-dose chemotherapy and OKHN are applied as standard treatment. OKHN increases cure rates, prolongs progression-free and overall survival (7). The application of a triple combination containing bortezomib is used as a standard in induction therapy in international myeloma centers (7,8). Depending on their physical condition and specific complications, patients who are not suitable for stem cell transplantation are treated differently.treatment options are available. Treatment options including bortezomib in patients with renal insufficiency and lenalidomide in patients with neuropathy can be given (9). There is usually no cure in Multiple Myeloma, the majority of patients receive second-line and other-line treatments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Self Acupressure, Sleep, Fatigue

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental:
Arm Type
Experimental
Arm Description
Self acupressure
Arm Title
Control
Arm Type
No Intervention
Arm Description
Routine maintenance will be applied.
Intervention Type
Other
Intervention Name(s)
Self acupressure
Intervention Description
patients will do self acupressure
Primary Outcome Measure Information:
Title
Pitssburg Sleep Quality Index
Description
It was developed by Buysse et al. (1989) (34). The scale is a safe and consistent questionnaire that evaluates the amount of sleep, sleep quality, presence and severity of sleep disorders in individuals in the last month. It was adapted into Turkish by Ağargün et al. (1996) (35). There are seven components in PUKI. These components are subjective sleep quality (component 1), sleep latency (component 2), sleep duration (component 3), habitual sleep efficiency (component 4), sleep disturbance (component 5), sleep medication use (component 6) and daytime dysfunction. (component 7). The evaluation score of each item is between 0-3. The total score obtained varies between 0-21. The higher the score, the worse the sleep quality.
Time Frame
4 week
Title
Piper Fatigue Scale
Description
The Piper Fatigue Scale was developed in 1987 by Piper et al. It was developed by.The Turkish validity and reliability study of the scale was conducted by Can in 2001 (37). The scale evaluates the individual's subjective perception of fatigue in four sub-dimensions. These; behavior/violence sub-dimension evaluating the effect and severity of fatigue on activities of daily living (ADLs (6 items; 2-7); affect sub-dimension, which includes the emotional meaning attributed to fatigue (5 items; 8-12); it is the sensory sub-dimension (5 items; 13-17) that reflects the mental, physical and emotional symptoms of fatigue, and the cognitive/spiritual sub-dimension that reflects the effect of fatigue on cognitive functions and mental state (6 items; 18-23). As a result of the average score; 0 points are interpreted as no fatigue, 1-3 points as mild fatigue, 4-6 points as moderate fatigue, 7-10 points as severe fatigue.
Time Frame
4 week
Title
Visual Analog Scale
Description
Patients are asked to show the intensity of pain on a 10 cm long vertical or horizontal line during activity or rest. It has numbered shapes ranging from 1-10. The line has 0 at the beginning and 10 at the end. 10 means unbearable pain, 0 means no pain. The VAS scale is frequently used in the evaluation of pain severity. While the patient marks the pain he/she has felt on this line, each point marked is measured in cm.
Time Frame
4 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Having a scale score of >5 on the Piper Fatigue Scale Having a score of >5 on the Pittsburgh Sleep Quality Scale Pain severity is 5 points or higher according to the Visual Analog Scale Exclusion criteria; Using acupressure and similar integrative treatment methods, Having a verbal communication disability (hearing and speaking), Having a diagnosed psychiatric disorder,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gülcan B.TURAN, PHD
Phone
05065576086
Email
glcnbah@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Melih Ulupınar
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülcan B.TURAN
Organizational Affiliation
Elazığ /Merkez/Turkey/23000
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gülcan B Turan
City
Elazığ
State/Province
Merkez
ZIP/Postal Code
23100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melih Ulupınar
Phone
05433060918

12. IPD Sharing Statement

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The Effect of Self Acupressure Application on Pain, Fatigue and Sleep Quality in Multiple Myeloma Patients

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