Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05576701 |
| Other study ID # |
BBal |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2022 |
| Est. completion date |
September 1, 2022 |
Study information
| Verified date |
February 2023 |
| Source |
Bozok University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Background: A randomized controlled study was conducted on the effects of laughter therapy on
increasing the acceptance of the disease, compliance with treatment and comfort levels in
patients receiving hemodialysis treatment.
Materials and methods: The study was conducted with 42 (experimental group=21, control
group=21) patients treated in the hemodialysis unit. Eight sessions of laughter yoga were
applied to the hemodialysis patients in the experimental group for four weeks, two days a
week. Data were used on the Patient Information Form, the Acceptance Scale, the End Stage
Renal Failure - Compliance Scale, and the Hemodialysis Comfort Scale.
Description:
Kidney Failure is an important public health problem due to its increasing prevalence and
high costs worldwide. Especially patients in the end stage of renal failure (ESRD) are faced
with a life-threatening chronic disease. These patients need lifelong treatment and care to
minimize the negative effects of impaired kidney function and to maintain life.
In the treatment and recovery processes of chronic diseases such as kidney failure,
individuals' acceptance of the disease, compliance with the treatment and their comfort level
are very important. The stage of acceptance of the disease is when the individual learns to
live with the chronic disease by adapting to various complications and changes related to the
chronic disease. Not accepting the disease results in submission to the problems brought
about by the disease and causes an increase in the sense of dependency and a decrease in the
sense of self-efficacy and self-esteem. It is very difficult for patients with end-stage
renal disease who receive hemodialysis (HD) treatment among chronic diseases to accept the
disease because they are affected by many physical, mental, spiritual and social aspects. It
has been reported that patients receiving HD treatment often experience problems in the
acceptance process of the disease. In the literature, it has been emphasized that acceptance
of the disease is effective in reducing the physical, psychosocial and emotional problems
caused by HD treatment. In addition, it has been shown that accepting the disease is
effective in increasing the quality of life by reducing symptoms such as fatigue,
constipation, loss of appetite, sexual dysfunction and stress in HD patients. On the other
hand, it has been determined that individuals with low acceptance level of the disease have
increased complaints about the disease and treatment. In studies related to the subject, it
has been determined that patients' acceptance of the disease is at different levels.
Another important step in the treatment and recovery processes of chronic diseases is
compliance with treatment. Compliance with treatment in the management of HD disease greatly
affects the success of treatment. Compliance with treatment in HD patients; It is considered
as compliance with fluid-diet-drug intake and participation in hemodialysis sessions. In
studies, 55-77% of individuals receiving HD treatment have fluid restriction 30-70% diet
restriction, 38-75% of drug intake and participation in 30-69% HD sessions have been found to
have problems with it. This situation increases hospitalization, morbidity and mortality
rates in individuals receiving HD treatment and creates a heavy burden on the health system.
Therefore, it is important to increase patients' acceptance of the disease and their
compliance with treatment.
Many physical and psychosocial symptoms occur during the disease and treatment processes, and
the care needs of individuals who experience physical, social, economic and psychological
problems increase, and there is a significant decrease in the quality of life and comfort.
Helping patients with their needs, providing peace and being able to overcome problems gain
priority. Therefore, the comfort that defines this situation; plays an important role in the
care of individuals with chronic diseases. Comfort; It is defined as meeting the needs of
individuals, solving their problems, reaching the desired result and peace by considering
them as a whole in terms of physical, psychological, social and environmental aspects. Today,
many complications and unmet basic needs of individuals with chronic diseases affect their
comfort levels negatively. In the studies conducted, the comfort level of individuals
receiving HD treatment is low and moderate. In the literature, problems such as painful
invasive procedures, fatigue, decrease in energy, itching, bone/joint pain, numbness or
tingling in the feet, sleep problems, dry mouth, decreased sexual desire and arousal
experienced by individuals who receive HD treatment can lower their comfort levels.
negatively. In order for patients to cope with the problems related to HD treatment, the
level of comfort needs to be increased.
It is seen that some complementary methods are used in the literature to increase the health
level of patients receiving HD treatment and to ensure that they can lead a quality life. One
of these methods is laughter therapy. Laughter therapy; Developed in India in 1995, yoga is a
group-based initiative that includes breathing exercises and simulated laughter. It is also a
type of exercise done by singing songs, laughing for no reason and playing childish games.
Laughter therapy for cardiovascular disease; irritable bowel syndrome, chronic obstructive
pulmonary disease, diabetes, cancer. It has been dealt with many diseases such as and
Parkinson's and it has been found to have beneficial effects on these diseases. In a
randomized controlled experimental study conducted by Bennet et al. in patients receiving HD
treatment, it was found that laughter therapy reduced the symptoms of depression. In the
study of Sousa et al., it was determined that laughter therapy increases subjective happiness
and significantly reduces symptoms of depression. In other studies conducted in patients
receiving HD treatment, laughter therapy has positive effects on anxiety, depression, stress,
and happiness was determined. There are also studies that show that laughter therapy
regulates blood pressure in patients receiving HD treatment. In all these studies, it was
observed that laughter therapy is a safe and feasible intervention in patients receiving HD
treatment. When the literature is examined, no studies have been found on the effects of
laughter therapy on the acceptance of the disease, compliance with the treatment and comfort
level, although complementary methods are frequently used in studies on patients. In this
direction, it was aimed to evaluate the effects of laughter therapy on acceptance of the
disease, compliance with treatment and comfort levels in patients receiving HD treatment.
