Effect of Laughter Therapy on Breast Cancer Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorProf. Dr. Cemil Tascıoglu Education and Research Hospital Organization
About this trial
The aim of this study is to examine the effect of laughter therapy applied to breast cancer patients before surgical intervention on distress, depression and psychological well-being of patients.
This research will be carried out as an experimental research with a randomised control group.
The population of the study will consist of breast cancer patients diagnosed with breast cancer in a city hospital and scheduled for surgery in the breast-endocrine surgery clinic. The research will be carried out with patients who meet the inclusion criteria and agree to participate in the study. The sample size for the study was calculated using the G\* Power 3.1.9.7 programme (Faul et al., 2007). In the calculation, since there was no similar study for two-way mixed design analysis of variance, the required sample size was calculated as 48, 24 in each group, based on the medium effect size (effect size f=0.25), 5% margin of error (alpha=0.05), inter-measurement correlation value 0.5 and 80% power (1-β=0.80). Considering the data losses, the number was increased by 20% and a total of 56 patients in the intervention and control groups constituted the sample of the study.
Hypothesis(es):
H1: The effect of laughter therapy applied to breast cancer patients on distress over time is different in the experimental and control groups.
H2: The effect of laughter therapy applied to breast cancer patients on depression over time is different in the experimental and control groups.
H3: The effect of laughter therapy applied to breast cancer patients on psychological well-being according to time is different in experimental and control groups.
In obtaining the research data; Personal Information Form, Distress Thermometer, Psychological well-being scale prepared by the researchers in line with the literature will be used.
The research data will be collected face-to-face through data collection forms from breast cancer patients diagnosed with breast cancer and scheduled for surgery in the breast-endocrine surgery clinic. Individuals who agree to participate in the study and meet the inclusion criteria will be assigned to the experimental and control groups by providing randomisation. Which caregivers will be in the intervention group and which will be in the control group will be determined according to the randomisation table determined by https://www.randomizer.org/ over the internet. Group 1: Intervention Group, Group 2: Control Group. Data collection tools will be applied to the individuals in the experimental and control groups as a pre-test. Individuals in the experimental group will receive laughter therapy three days a week for 30-45 minutes (6 sessions). Individuals in the control group will receive only standard nursing care. Data collection tools will be applied to the individuals in both groups for post-test, 1 and 3-month follow-up tests immediately after all laughter sessions with the experimental group are completed.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Voluntary acceptance to participate in the study,
Being diagnosed with breast cancer and being in the patient group in which surgical operation is planned,
Not having participated in laughter yoga practice before,
Being literate,
Disqualifiers
Not wanting to participate in the study,
Being in the patient group with a condition recommended not to do laughter yoga (having undergone surgery in the abdominal region in the last three months, uncontrolled hypertension, glaucoma, hernia, epilepsy),
Not having participated in any of the laughter yoga sessions,
Having physical restriction/respiratory problems and not being able to perform yoga movements.
Trial design
Design model
Parallel
Treatments tested in this trial
laughter therapy
Other interventionLaughter therapy/yoga, classified as complementary therapy in medicine, is a unique form of exercise consisting of a combination of laughter, yoga and breathing techniques that allows us to laugh without any sense of humour.
routine nursing care
Other interventionroutine nursing care
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: Experimental groupExperimental treatment 1 intervention
Group B: control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Laughter therapy will be applied to individuals with breast cancer and their levels of psychological distress will be measured.Laughter therapy will be applied to individuals with breast cancer and their psychological distress levels will be measured.
Meme kanserine sahip olan bireylere kahkaha terapisi uygulanacak ve pskilojik sıkıntı düzeyleri ölçülecektir. Laughter therapy will be applied to individuals with breast cancer and their levels of psychological distress will be measured. (Face to face training will be given)
Time frame
2 weeks2
Laughter therapy will be applied to individuals with breast cancer and their depression levels will be measured.
Laughter therapy will be applied to individuals with breast cancer and their depression levels will be measured (Face to face training will be given)
Time frame
2 weeks3
Laughter therapy will be applied to individuals with breast cancer and their psychological well-being levels will be measured.
Laughter therapy will be applied to individuals with breast cancer and their psychological well-being levels will be measured (Face to face training will be given)
Time frame
2 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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