Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05842265
Status:
RECRUITING
Last Update Posted:
2023-06-07
First Post:
2023-04-24
Brief Title:
The Effect of Self Acupressure Application on Pain Fatigue and Sleep Quality in Multiple Myeloma Patients
Sponsor:
Ataturk University
Organization:
Ataturk University
Study Overview
Official Title:
The Effect of Self Acupressure Application on Pain Fatigue and Sleep Quality in Multiple Myeloma Patients
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Multiple Myeloma occurs with damaging bone lesion hypercalcemia anemia and renal failure as a result of secretion of monoclonal protein in serum andor 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
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 andor 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 cellplasmablast 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 78 Depending on their physical condition and specific complications patients who are not suitable for stem cell transplantation are treated differentlytreatment 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
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 cellplasmablast 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 78 Depending on their physical condition and specific complications patients who are not suitable for stem cell transplantation are treated differentlytreatment 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None