Laughter TherapyNCT05391373
Effect of Laughter Therapy on Perceived Stress and Quality of Life
A study testing Laughter therapy in people with Laughter Therapy, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial summary
Breast cancer is the most common type of cancer seen in women worldwide and ranks first. Chemotherapy is one of the commonly used methods of treatment in breast cancer. Physiological and psychological symptoms that occur due to chemotherapy treatment affect women negatively and reduce their quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Laughter Therapy
- What is being tested?
- Laughter therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Feb 2022to 12 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and older women,
- Stages II or III breast cancer
- Receiving Pacitaxel chemotherapy regimen per a week
Who cannot join
- Using any complementary and alternative (CAM) treatment method during practice
- Having psychological diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Bakircay University Health Sciences Faculty
Izmir, 35560
About this study
Official title: Effect of Laughter Therapy on Perceived Stress and Quality of Life in Women With Breast Cancer: An Assessor-blinded, Parallel Group, Randomized Controlled Trial
Breast cancer is the most common type of cancer seen in women worldwide and ranks first. Chemotherapy is one of the commonly used methods of treatment in breast cancer. Physiological and psychological symptoms that occur due to chemotherapy treatment affect women negatively and reduce their quality of life. For this reason, there is a need for an intervention that could decrease psychological symptoms such as stress and improve quality of life in women with breast cancer. In the literature, it is stated that laughter therapy which is one of the non-pharmacological methods, can be an effective nursing intervention to decrease stress and improve the quality of life in women with breast cancer.
Read the detailed description
This an assessor-blinded, parallel group randomized controlled trial aimed that investigating the effect of laughter therapy on perceived stress and quality of life in women with breast cancer.This trial was conducted in the chemotherapy outpatient clinic of training and research hospital located in Turkey. All patients were women with breast cancer who received a once-weekly Paclitaxel regimen.
- Conditions
- Laughter Therapy
- Being tested
- Laughter therapy
- Keywords
- Perceived stress, Quality of life, Laughter therapy, Breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter therapyBehavioural
Each session started with a 10-minute breathing exercise accompanied by relaxing music, followed by 20-minute laughing exercises. Afterwards, the session was ended with a 10-minute meditation accompanied by relaxing music.
| Study group | Role | What they receive |
|---|---|---|
| Laughter Therapy Group | Experimental | The women with breast cancer in the intervention group received two sessions of laughter therapy per week for eight weeks.Each laughter therapy session lasted 40 minutes. Receives: Behavioral: Laughter therapy |
| Control group | No intervention | The control group did not receive any intervention during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale
The scale consists of 14 items in total and was designed to measure how stressful the changing situations in the individual's life are perceived.The scale is a 5-point Likert-type scale with each item ranging from "never (0)" to "very often (4)". 7 of the scale items with positive expressions are scored in reverse and the total score that can be obtained from the scale ranges from 0 to 56. Eskin et al. performed the validity and reliability study of the Turkish version of Perceived Stress Scale and the internal consistency of the scale was determined to be 0.82.
Measured: The scale was filled in the baseline (before the beginning of the Laughter therapy), 5th and 9th weeks.
Secondary outcomes (1)
Quality of Life Scale (SF-12)
The scale evaluates the quality of life of individuals.The scale consists of 12 items and two sub-dimensions in total.While the items related to physical and emotional role were answered as yes or no, the other items had likert type options ranging between 3 and 6. While the Physical Component Summary-12 (PCS-12) score was obtained from the sub-dimensions of general health, physical functionality, physical role and body pain; The Mental Component Summary-12 (MCS-12) score was obtained from the sub-dimensions of social functionality, emotional role, mental health and energy. Both the PCS-12 and MCS-12 scores range from 0 to 100, with the higher score representing better health.Soylu et al. performed the validity and reliability study of the Turkish version of Quality of Life Scale (SF-12) and the internal consistency of the scale was determined to be 0.73.
Measured: The scale was filled in the baseline (before the beginning of the Laughter therapy), 5th and 9th weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start17 Feb 2022
- Primary completion31 May 2022
- Study completion12 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laughter TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pinar Zorba Bahceli, PhD RN, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391373
- Sponsor's protocol ID
- 2021/271
- Status last verified
- Jun 2022
- First submitted
- 21 May 2022
- Last updated
- 30 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laughter Therapy on Perceived Stress and Quality of Life in Women With Breast Cancer: An Assessor-blinded, Parallel Group, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05391373
- Acronym / sponsor ID
- 2021/271
- Conditions
- Laughter Therapy
- Keywords
- Perceived stress, Quality of life, Laughter therapy, Breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 12 Jun 2022 (actual)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breast cancer is the most common type of cancer seen in women worldwide and ranks first. Chemotherapy is one of the commonly used methods of treatment in breast cancer. Physiological and psychological symptoms that occur due to chemotherapy treatment affect women negatively and reduce their quality of life. For this reason, there is a need for an intervention that could decrease psychological symptoms such as stress and improve quality of life in women with breast cancer. In the literature, it is stated that laughter therapy which is one of the non-pharmacological methods, can be an effective nursing intervention to decrease stress and improve the quality of life in women with breast cancer.
Detailed description
This an assessor-blinded, parallel group randomized controlled trial aimed that investigating the effect of laughter therapy on perceived stress and quality of life in women with breast cancer.This trial was conducted in the chemotherapy outpatient clinic of training and research hospital located in Turkey. All patients were women with breast cancer who received a once-weekly Paclitaxel regimen.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laughter Therapy Group | Experimental | Behavioral: Laughter therapyThe women with breast cancer in the intervention group received two sessions of laughter therapy per week for eight weeks.Each laughter therapy session lasted 40 minutes. |
| Control group | No intervention | –The control group did not receive any intervention during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years and older women,
- Stages II or III breast cancer
- Receiving Pacitaxel chemotherapy regimen per a week
Key exclusion criteria (2 listed)
- Using any complementary and alternative (CAM) treatment method during practice
- Having psychological diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laughter therapyEach session started with a 10-minute breathing exercise accompanied by relaxing music, followed by 20-minute laughing exercises. Afterwards, the session was ended with a 10-minute meditation accompanied by relaxing music. | Behavioural | Laughter Therapy Group |
Primary outcome
Perceived Stress Scale
Time frame: The scale was filled in the baseline (before the beginning of the Laughter therapy), 5th and 9th weeks.
The scale consists of 14 items in total and was designed to measure how stressful the changing situations in the individual's life are perceived.The scale is a 5-point Likert-type scale with each item ranging from "never (0)" to "very often (4)". 7 of the scale items with positive expressions are scored in reverse and the total score that can be obtained from the scale ranges from 0 to 56. Eskin et al. performed the validity and reliability study of the Turkish version of Perceived Stress Scale and the internal consistency of the scale was determined to be 0.82.
1 secondary outcome
Quality of Life Scale (SF-12)
Time frame: The scale was filled in the baseline (before the beginning of the Laughter therapy), 5th and 9th weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Laughter Therapy
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Exploring the Evolution of Quality of Life and Emotional Distress Among Cancer Patients Participating in Mind-body Therapies
Cancer, Mind-Body Therapies
Not yet recruitingPhase 3
Sustained Mood Improvement With Laughing Gas Exposure
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The Effect of Laughter Yoga Practice in Hypertension Patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laughter therapy in people with Laughter Therapy, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale (time frame: The scale was filled in the baseline (before the beginning of the Laughter therapy), 5th and 9th weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.