NCT03687788

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 26, 2018

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 27, 2018

Completed
Last Updated

September 27, 2018

Status Verified

September 1, 2018

Enrollment Period

7 days

First QC Date

September 24, 2018

Last Update Submit

September 25, 2018

Conditions

Keywords

Laughter therapy; Loneliness; Life Satisfaction; Older adults; Nursing

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change from Baseline De Jong Gierveld Loneliness Scale (DJGLS) scores at 6 weeks

Secondary Outcomes (1)

  • Life Satisfaction Scale (LSS) scores

    Change from Baseline Life Satisfaction Scale (LSS) scores at 6 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

Intervention group received laughter therapy twice a week for six weeks.

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.

Interventions

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.

Intervention Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • participants had to be 65 or older and be able to maintain independence in daily activities.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University Health Science Faculty

Konya, Selcuklu, 42250, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Personal Satisfaction

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asistant Professor

Study Record Dates

First Submitted

September 24, 2018

First Posted

September 27, 2018

Study Start

February 26, 2018

Primary Completion

March 5, 2018

Study Completion

April 6, 2018

Last Updated

September 27, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations