Clinical trial NCT06063616: The Effect of Reiki Application on Pain Severity and Quality of Life in Patients Receiving Hemodialysis Treatment
Official title: The Effect of Reiki Application on Pain Severity and Quality of Life in Patients Receiving Hemodialysis Treatment: Qualitative and Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis
Keywords: Hemodialysis
Reiki
Pain
Quality of life
Nursing
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2023-10-02
Enrollment: 80
Sex: ALL
Minimum age (years): 26
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Purpose The purpose of this study is to determine the effect of Reiki on pain intensity and quality of life in patients receiving hemodialysis treatment.

Materials and methods The research was conducted as a qualitative study using pretest-posttest, double-blind, randomized controlled study and semi-structured in-depth interview. In this study, patients receiving HD treatment in three separate private dialysis centers in Turkey were randomized to Reiki and sham Reiki groups. In the first three hours of the HD session, in the first three hours of the HD session, three sessions a week for a total of 12 sessions for 30 minutes (min), the first level is applied to 9 main points (crown, forehead, throat, heart, solar plexus, sacral and root chakras, knees, ankles and feet). While applying Reiki, the sham Reiki group was touched at the same points for the same period of time by the uninitiated practitioner. At the beginning and end of the study, Kidney Disease Quality of Life (KDQOLTM-36) scores, Visual Analogue Scale (VAS-Pain) before and after the application, and psychodynamic reactions experienced during the Reiki application after the application were evaluated. At the end of the research, the Reiki group's opinions about the Reiki experience were collected using a form consisting of semi-structured questions.

Detailed description: The fifth stage of chronic kidney disease 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 the quality of life, it is actually a form of treatment that brings with it different problems. Patients receiving HD treatment experience many physical and psychological symptoms such as pain, fatigue, dyspnea, sleep problems, restless leg 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 patient's 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.

Pharmacological and/or complementary and integrative treatment (TIT) methods are used in the management of pain in patients receiving hemodialysis treatment are used. In pharmacological treatment, analgesics with better metabolic clearance such as fentanyl and hydromorphone are preferred. However, patients' inability to fully express their pain, their unwillingness to increase the already existing medication burden, fear of addiction or side effects of the medications to be used, ethnic or cultural factors, healthcare professionals' inability to evaluate pain adequately 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. According to the results of studies conducted on different patient groups; Reiki's vital signs, hemoglobin and hematocrit levels, wound healing, digestive problems, acute and chronic pain, sleep, fatigue, anxiety, fear, depression, stress, relaxation, analgesic use, self-esteem, patient satisfaction, hospital stay, communication, life It has been determined that its quality has positive effects on the side effects of chemotherapy and radiotherapy. However, the results of these studies require careful interpretation due to the limited number of randomized controlled studies, lack of sham and control groups, insufficient sample sizes, differences in population characteristics and protocol, frequency and duration.

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, since it increases the quality of life by reducing the severity of pain when applied together with standard treatment, it stands out as one of the different approaches that nurses, especially those who have been with the patient for a long time, can offer to the patient in providing pain management. Based on this point, this study aimed to determine the effect of first-level Reiki, which is applied for a total of 12 sessions for 30 minutes three times a week, in the first three hours of HD, on pain intensity and quality of life in individuals receiving HD treatment.

Eligibility criteria: Inclusion Criteria:

* Those who are 18 years of age and over,
* Able to speak Turkish and have no communication problems,
* Receiving HD treatment three times a week for 6 months or longer,
* Without a pacemaker,
* Pain intensity of 4 or more based on the average of two VAS-Pain measurement values evaluated one week apart,
* Having lower extremity pain,
* Does not have any psychiatric disorder,
* Patients over the age of 65 with a Standardized Mini Mental Test (SMMT) score of 24 points and above were included.

Exclusion Criteria:

* Those who are under 18 years of age,
* Having hearing problems,
* Those who do not speak Turkish and cannot communicate,
* Having a pacemaker installed,
* Pain intensity of 3 or less according to the average of two VAS-Pain measurement values evaluated one week apart,
* No lower extremity pain,
* Having any psychiatric disorder,
* Those who have previously received energy-based therapies such as Reiki/therapeutic touch/healing touch,
* Patients over the age of 65 with an SMMT value below 24 were not included in the study.

Primary outcomes:
measure: Pain severity measurement
timeFrame: Day 1
measure: Initial quality of life measurement
timeFrame: Day 1
Secondary outcomes:
measure: Pain severity measurement at the end of the 12th session
timeFrame: 4 weeks later
measure: Quality of life measurement at the end of the 12th session
timeFrame: 4 weeks later
Other outcomes:
Locations:
city: Çorum
country: Turkey
facility: Sultan Çeçen
Study officials:
References:
citation: Zins S, Hooke MC, Gross CR. Reiki for Pain During Hemodialysis: A Feasibility and Instrument Evaluation Study. J Holist Nurs. 2019 Jun;37(2):148-162. doi: 10.1177/0898010118797195. Epub 2018 Aug 31.