Older AdultsNCT03687788
The Effect of Laughter Therapy on Life Satisfaction and Loneliness
A study testing Laughter Therapy in people with Older Adults, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
Life satisfaction and loneliness are two important issues affecting the quality of life of the elderly. Older adults living in nursing homes experience the feeling of loneliness more and their life satisfaction decreases. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adults
- 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
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Feb 2018to 6 Apr 2018
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- participants had to be 65 or older and be able to maintain independence in daily activities.
Who cannot join
- having severe hearing or perceptual deficits that impaired communication; having dementia, Alzheimer's disease, depression, uncontrolled diabetes, hypertensive disease and surgical operations with the risk of bleeding.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selcuk University Health Science Faculty
Konya, Selcuklu, 42250
About this study
Official title: The Effect of Laughter Therapy on Life Satisfaction and Loneliness in Older Adults Living in a Nursing Home: A Parallel Group Randomized Control Trial
Life satisfaction and loneliness are two important issues affecting the quality of life of the elderly. Older adults living in nursing homes experience the feeling of loneliness more and their life satisfaction decreases. For this reason, there is a need for an intervention that could increase the life satisfaction of the older adults and decrease their loneliness.
The aim of the research was to examine the effects of laughter therapy on life satisfaction and loneliness in older adults living in a nursing home.
Read the detailed description
A single-blinded, parallel group randomized controlled trial was used to evaluate the impact of laughter therapy on life satisfaction and loneliness in older adults living in a nursing home.
The study was conducted in the only nursing home in Hatay province of Turkey.
The study participants were older adults living in a nursing home. A total of 62 older adults formed the experimental group (n = 31) and the control group (n = 31).
In order to ensure randomization and equal gender distribution, first, two groups (men and women) were formed. After the stratification process, five blocks consisting of six people and one group consisting of four people were formed using the permuted blocked randomization method. After the formation of the blocks, the elderly were randomly assigned to the experimental and the control group using a random number table. The experimental group received laughter therapy twice a week for 6 weeks and the usual care. The control group received only the usual care. To collect data, a personal information form, the De Jong Gierveld Loneliness Scale (DJGLS) and the Life Satisfaction Scale (LSS) were used.
- Conditions
- Older Adults
- Being tested
- Laughter Therapy
- Keywords
- Laughter therapy; Loneliness; Life Satisfaction; Older adults; Nursing
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter TherapyBehavioural
Laughter therapy program was composed of four steps. The first step, which took 10 minutes, had warm-up exercises including gentle stretching and hand clapping. The second step, which included deep breathing exercises and hand clapping, took 5 minutes. The third step involved children's games and laughter exercises. In this step, the most common laughter exercises were milkshake laughter, bugi bugi laughter techniques, lion laughter, cell phone, hot soup laughter, hug laughter, bird laughter, dialogue with nonsense, speech exercises, laugh at one's own aches and pains exercises, argument laughter, brushing teeth and mouthwash exercises. The sessions included a combination of different laughter exercises. This step took 15 minutes. The last step, which included wishes and resting by breathing, took 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Intervention group received laughter therapy twice a week for six weeks. Receives: Behavioral: Laughter Therapy |
| Control Group | No intervention | The control group did not take part in the laughter therapy program. This group received the routine care given by the nurses in the center. |
What is being measured
The primary outcome is the main question the study is designed to answer.
De Jong Gierveld Loneliness Scale (DJGLS) scores
The De Jong Gierveld Loneliness Scale was originally developed by De Jong-Gierveld and Kamphuls (1985) and revised by De Jong Gierveld and Van Tilburg (1999). The 11-item DJGLS consists of two subscales: six negatively framed items measure emotional loneliness and five positively framed items measure social loneliness. The sum of these two subscales constitutes the general loneliness score. The scale is a Likert-type scale in which positive items are scored as 0 = yes, 1 = more or less, and 2 = no; and negative items are scored inversely as 2 = yes, 1 = more or less, and 0 = no. Total scores can range from 0 to 22, with a higher score denoting more severe loneliness. The DJGLS was tested for validity and reliability on Turkish population by Akgul and Yesilyaprak (2015), with Cronbach's alpha reliability coefficient of 0.85. In the present study, Cronbach's alpha was 0.87.
Measured: Change from Baseline De Jong Gierveld Loneliness Scale (DJGLS) scores at 6 weeks
Secondary outcomes (1)
Life Satisfaction Scale (LSS) scores
The Life Satisfaction Scale was developed by Diener et al. (1985). This five-point Likert scale, which has one factor structure, consists of 5 items and evaluates the life satisfaction of the individuals in general. The total score that could be obtained from the scale ranges from 5 to 25, and a higher scale score indicates a higher level of life satisfaction.
The LSS was tested for validity and reliability within the Turkish population by Daglı and Baysal (2016), with Cronbach's alpha reliability coefficient of 0.88. In the present study, Cronbach's alpha was 0.89.
Measured: Change from Baseline Life Satisfaction Scale (LSS) scores at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start26 Feb 2018
- Primary completion5 Mar 2018
- Study completion6 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pinar Zorba Bahceli, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687788
- Sponsor's protocol ID
- 2017/185
- Status last verified
- Sep 2018
- First submitted
- 24 Sep 2018
- Last updated
- 27 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kuru Alici N, Zorba Bahceli P. Effects of Laughter Therapy on Life Satisfaction and Loneliness in Older Adults Living in Nursing Homes in Turkey: A Parallel Group Randomized Controlled Trial. Rehabil Nurs. 2021 Mar-Apr 01;46(2):104-112. doi: 10.1097/RNJ.0000000000000266.
PubMed 33646727
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laughter Therapy on Life Satisfaction and Loneliness in Older Adults Living in a Nursing Home: A Parallel Group Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03687788
- Acronym / sponsor ID
- 2017/185
- Conditions
- Older Adults
- Keywords
- Laughter therapy; Loneliness; Life Satisfaction; Older adults; Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 5 Mar 2018 (actual)
- Study completion
- 6 Apr 2018 (actual)
- First posted
- 27 Sep 2018 (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.
Life satisfaction and loneliness are two important issues affecting the quality of life of the elderly. Older adults living in nursing homes experience the feeling of loneliness more and their life satisfaction decreases. For this reason, there is a need for an intervention that could increase the life satisfaction of the older adults and decrease their loneliness.
The aim of the research was to examine the effects of laughter therapy on life satisfaction and loneliness in older adults living in a nursing home.
Detailed description
A single-blinded, parallel group randomized controlled trial was used to evaluate the impact of laughter therapy on life satisfaction and loneliness in older adults living in a nursing home.
The study was conducted in the only nursing home in Hatay province of Turkey.
The study participants were older adults living in a nursing home. A total of 62 older adults formed the experimental group (n = 31) and the control group (n = 31).
In order to ensure randomization and equal gender distribution, first, two groups (men and women) were formed. After the stratification process, five blocks consisting of six people and one group consisting of four people were formed using the permuted blocked randomization method. After the formation of the blocks, the elderly were randomly assigned to the experimental and the control group using a random number table. The experimental group received laughter therapy twice a week for 6 weeks and the usual care. The control group received only the usual care. To collect data, a personal information form, the De Jong Gierveld Loneliness Scale (DJGLS) and the Life Satisfaction Scale (LSS) were used.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Laughter TherapyIntervention group received laughter therapy twice a week for six weeks. |
| Control Group | No intervention | –The control group did not take part in the laughter therapy program. This group received the routine care given by the nurses in the center. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- participants had to be 65 or older and be able to maintain independence in daily activities.
Key exclusion criteria (1 listed)
- having severe hearing or perceptual deficits that impaired communication; having dementia, Alzheimer's disease, depression, uncontrolled diabetes, hypertensive disease and surgical operations with the risk of bleeding.
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 TherapyLaughter therapy program was composed of four steps. The first step, which took 10 minutes, had warm-up exercises including gentle stretching and hand clapping. The second step, which included deep breathing exercises and hand clapping, took 5 minutes. The third step involved children's games and laughter exercises. In this step, the most common laughter exercises were milkshake laughter, bugi bugi laughter techniques, lion laughter, cell phone, hot soup laughter, hug laughter, bird laughter, dialogue with nonsense, speech exercises, laugh at one's own aches and pains exercises, argument laughter, brushing teeth and mouthwash exercises. The sessions included a combination of different laughter exercises. This step took 15 minutes. The last step, which included wishes and resting by breathing, took 10 minutes. | Behavioural | Intervention Group |
Primary outcome
De Jong Gierveld Loneliness Scale (DJGLS) scores
Time frame: Change from Baseline De Jong Gierveld Loneliness Scale (DJGLS) scores at 6 weeks
The De Jong Gierveld Loneliness Scale was originally developed by De Jong-Gierveld and Kamphuls (1985) and revised by De Jong Gierveld and Van Tilburg (1999). The 11-item DJGLS consists of two subscales: six negatively framed items measure emotional loneliness and five positively framed items measure social loneliness. The sum of these two subscales constitutes the general loneliness score. The scale is a Likert-type scale in which positive items are scored as 0 = yes, 1 = more or less, and 2 = no; and negative items are scored inversely as 2 = yes, 1 = more or less, and 0 = no. Total scores can range from 0 to 22, with a higher score denoting more severe loneliness. The DJGLS was tested for validity and reliability on Turkish population by Akgul and Yesilyaprak (2015), with Cronbach's alpha reliability coefficient of 0.85. In the present study, Cronbach's alpha was 0.87.
1 secondary outcome
Life Satisfaction Scale (LSS) scores
Time frame: Change from Baseline Life Satisfaction Scale (LSS) scores at 6 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 27 Sep 2018.
- Derived from this study: PubMed 33646727Kuru Alici N, Zorba Bahceli P. Effects of Laughter Therapy on Life Satisfaction and Loneliness in Older Adults Living in Nursing Homes in Turkey: A Parallel Group Randomized Controlled Trial. Rehabil Nurs. 2021 Mar-Apr 01;46(2):104-112. doi: 10.1097/RNJ.0000000000000266.
- Individual participant dataSharing planned: No
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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 Older Adults, run by Selcuk 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 1 inclusion and 1 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 27 Sep 2018. 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?
De Jong Gierveld Loneliness Scale (DJGLS) scores (time frame: Change from Baseline De Jong Gierveld Loneliness Scale (DJGLS) scores at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03687788, which also lists 1 linked publication.
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 27 Sep 2018.