Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06519136
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
The Effect of Second Level Reiki on Pain Severity and Quality of Life in Patients Receiving Hemodialysis Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Reiki Therapy on Pain Severity and Quality of Life in Patients Undergoing Hemodialysis A Follow-Up and Evaluation Study of First-Level Reiki Versus Second-Level Reiki Application
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Purpose The aim of this study is to determine the effect of 20-minute second-level Reiki application for 4 consecutive days on pain intensity and quality of life in patients receiving hemodialysis HD treatment and It is a comparison of the follow-up results of the first level Reiki applied within the scope of the doctoral thesis and the second level Reiki applications to be applied within the scope of this study
Method The study will be conducted as a pre-test-post-test double-blind randomized controlled trial After obtaining Ethical Committee approval participants in the Reiki group will receive 20-minute Reiki sessions at the second level daily from 700 PM to 900 PM for four days while participants in the sham Reiki group will be informed that distant energy application will be performed but no actual treatment will be administered The researcher will plan to administer second-level Reiki sessions to 8 patients daily Throughout the study patients in both groups will continue their routine treatments At the beginning and three weeks after the end of the intervention Kidney Disease Quality of Life Scale KDQOLTM-36 scores will be collected face-to-face at HD centers before and after the intervention Visual Analog Scale for Pain VAS-Pain additionally psychodynamic responses experienced during the first and last Reiki sessions will be evaluated by three blinded assessors via telephone in both study groups
Results Statistical analyses of the data will be conducted using the Statistical Package for Social Sciences Version 220 SPSS Inc Chicago IL USA License Hitit University Depending on the homogeneity of the data distribution appropriate parametric or nonparametric tests will be performed for data evaluation
Method The study will be conducted as a pre-test-post-test double-blind randomized controlled trial After obtaining Ethical Committee approval participants in the Reiki group will receive 20-minute Reiki sessions at the second level daily from 700 PM to 900 PM for four days while participants in the sham Reiki group will be informed that distant energy application will be performed but no actual treatment will be administered The researcher will plan to administer second-level Reiki sessions to 8 patients daily Throughout the study patients in both groups will continue their routine treatments At the beginning and three weeks after the end of the intervention Kidney Disease Quality of Life Scale KDQOLTM-36 scores will be collected face-to-face at HD centers before and after the intervention Visual Analog Scale for Pain VAS-Pain additionally psychodynamic responses experienced during the first and last Reiki sessions will be evaluated by three blinded assessors via telephone in both study groups
Results Statistical analyses of the data will be conducted using the Statistical Package for Social Sciences Version 220 SPSS Inc Chicago IL USA License Hitit University Depending on the homogeneity of the data distribution appropriate parametric or nonparametric tests will be performed for data evaluation
Detailed Description:
Chronic kidney disease CKD is the chronic progressive and irreversible loss of kidney functions associated with many causes and consists of a total of five clinical stages that require different treatment and care The fifth of these stages is called end-stage renal disease ESRD and hemodialysis HD is offered to patients as a renal replacement treatment option unless a successful kidney transplantation occurs at this stage Although HD treatment is a treatment option that aims to reduce mortality and morbidity rates and improve quality of life it can also bring about different problems caused by the disease and treatment Many physical and psychological symptoms are observed in patients receiving HD treatment such as pain fatigue dyspnea sleep problems restless legs syndrome itching muscle cramps nausea-vomiting loss of appetite constipation dry skin sexual dysfunction anxiety depression and delirium In addition these symptoms bring about social and economic problems and negatively affect the patients quality of life In patients with ESRD and receiving HD treatment The most common symptom is pain due to reasons such as accumulation of fluid and metabolic wastes comorbid causes such as diabetes cardiovascular and pulmonary diseases infections changes in the musculoskeletal system HD procedure carpal tunnel syndrome and anxiety It is known that hemodialysis patients experience moderate to severe pain and unless the pain they experience is eliminated the quality of life of individuals and their motivation for the continuity of treatment are negatively affected Therefore the importance of pain management in these patients increases considerably The essence of effective pain management is a multidisciplinary approach and the combined use of pharmacological and non-pharmacological methods When the studies are examined it is seen that pharmacological andor complementary and integrative treatment TIT methods are used in the management of pain in patients receiving HD treatment In pharmacological treatment non-opioid analgesics such as acetaminophen topical analgesics gabapentinoids and tricyclic antidepressants are primarily preferred However patients inability to fully express their pain their unwillingness to increase the already existing medication load fear of addiction or side effects of the medications to be used ethnic or cultural factors healthcare professionals inability to adequately evaluate pain and lack of training in pain management are among the reasons for HD patients There are difficulties in pain management due to reasons such as the lack of a guide on pain management For this reason patients prefer TIT methods such as yoga reflexology music therapy relaxation exercises aromatherapy acupressure and Reiki instead of drug treatment
Reiki one of the energy-based treatments that has attracted great attention from nurses among TIT methods in recent years It provides physical mental and emotional healing by balancing the disrupted energy flow
While only two studies examining the effect of Reiki on pain in patients receiving HD treatment have been found in the literature no studies investigating its effect on quality of life have been found Reiki is a method that can be easily learned is non-invasive does not require special equipment is cost-free easy to apply reduces the use of analgesics and has no side effects In addition when applied together with standard treatment it stands out as one of the different approaches that nurses can offer to the patient in providing pain management as it increases the quality of life by reducing the severity of pain Based on this point the doctoral thesis titled The Effect of Reiki Application on Pain Intensity and Quality of Life in Patients Receiving Hemodialysis Treatment has a mixed design It was conducted as a pretest-posttest double-blind randomized controlled study and a qualitative study with individual in-depth interviews In the study data it was observed that first level Reiki applied for a total of 12 sessions for 30 minutes three times a week in the first three hours of HD reduced the severity of pain improved mental health and positively affected the quality of life by reducing the symptoms and problems of kidney disease The fact that first level Reiki application takes a long time puts pressure on the practitioner considering the other workloads of nurse practitioners and a limited number of patients can benefit from this applicationThere is also a second level distance Reiki application in the literature that has been applied to different patient groups and examines the effect of Reiki on pain intensity In addition no study has been found in the literature examining the effect of second-level Reiki on pain intensity and quality of life in HD patients nor has there been any study examining how long the effect of Reiki application lasts Therefore this study aims to determine the effect of 20-minute second-level Reiki application for 4 consecutive days on pain intensity and quality of life in patients receiving HD treatment and to compare the follow-up results of first-level Reiki and second-level Reiki applications
Reiki one of the energy-based treatments that has attracted great attention from nurses among TIT methods in recent years It provides physical mental and emotional healing by balancing the disrupted energy flow
While only two studies examining the effect of Reiki on pain in patients receiving HD treatment have been found in the literature no studies investigating its effect on quality of life have been found Reiki is a method that can be easily learned is non-invasive does not require special equipment is cost-free easy to apply reduces the use of analgesics and has no side effects In addition when applied together with standard treatment it stands out as one of the different approaches that nurses can offer to the patient in providing pain management as it increases the quality of life by reducing the severity of pain Based on this point the doctoral thesis titled The Effect of Reiki Application on Pain Intensity and Quality of Life in Patients Receiving Hemodialysis Treatment has a mixed design It was conducted as a pretest-posttest double-blind randomized controlled study and a qualitative study with individual in-depth interviews In the study data it was observed that first level Reiki applied for a total of 12 sessions for 30 minutes three times a week in the first three hours of HD reduced the severity of pain improved mental health and positively affected the quality of life by reducing the symptoms and problems of kidney disease The fact that first level Reiki application takes a long time puts pressure on the practitioner considering the other workloads of nurse practitioners and a limited number of patients can benefit from this applicationThere is also a second level distance Reiki application in the literature that has been applied to different patient groups and examines the effect of Reiki on pain intensity In addition no study has been found in the literature examining the effect of second-level Reiki on pain intensity and quality of life in HD patients nor has there been any study examining how long the effect of Reiki application lasts Therefore this study aims to determine the effect of 20-minute second-level Reiki application for 4 consecutive days on pain intensity and quality of life in patients receiving HD treatment and to compare the follow-up results of first-level Reiki and second-level Reiki applications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None