Effects of Laughter Yoga on Hemodialysis Patients' Plasma-Beta Endorphin Levels, Pain Levels and Sleep Quality

November 21, 2019 updated by: Zülfünaz ÖZER, Istanbul Sabahattin Zaim University

Effects of Laughter Yoga on Hemodialysis Patients' Plasma-Beta Endorphin Levels, Pain Levels and Sleep Quality: A Randomized Controlled Trial

This study aimed to assess the effectiveness of laughter yoga on HD patients' plasma beta endorphin levels, pain levels and sleep quality.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

While there are studies conducted with laughter yoga on different patient groups in Turkey, no studies have been found on hemodialysis patients specifically. For this reason, it was thought that studies are needed which will prove the effect of laughter yoga practices on the plasma beta-endorphin levels, pain levels and sleep quality of hemodialysis patients.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Küçükçekmece
      • Istanbul, Küçükçekmece, Turkey, 34303
        • Istanbul Sabahattin Zaim University, Faculty of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • receiving treatment in a dialysis center
  • must be between 18 and 80 years old and willing to participate in the study
  • receiving HD treatment at least twice a week for a month or longer
  • having a pain level and above
  • level of 5 above according to the Pittsburgh Sleep Quality Index.

Exclusion Criteria:

  • not taking any medicine for sleeping disorder
  • not having any visual, hearing or communication impairments
  • not having any mental disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laughter yoga group, group doing laughter yoga
The duration of the laughter yoga was 30 minutes and a total of 16 sessions were performed on a twice-weekly basis.
Behavioral: Laughter yoga
The laughter yoga practice was initiated through clapping and warm-up exercises: hands were clapped keeping hands in parallel with each other and ensuring that the fingertips touched each other. To increase the energy level of the group, a rhythmic beat was added to the clapping in the form of 1-2, 1-2-3. While this was being sung a rhythm was tapped out on the floor by moving the feet up and down. Eye contact was constantly maintained with the participants. In the second phase, deep breathing exercises were performed. Participants were encouraged to inhale from the diaphragm. Individuals were asked to put their hands on their belly and inhale through the nose and then slowly exhale through the mouth. After the deep breathing exercise, the participants were encouraged to laugh through playing children's games in the third phase.
No Intervention: No laughter yoga group, group not doing laughter yoga

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beta-endorphin Level
Time Frame: 8 week
Blood samples were taken from all individuals who participated in the study, through their AVF fistulas by using 3.5 mL gel-based tubes and following antiseptic rules. Blood samples which were fully coagulated were centrifuged at 1500xg for 10 minutes and serums were obtained. The serum samples were separated into portions and kept at -80 °C until the analysis.
8 week
Visual Analog Scale
Time Frame: 8 week
The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm
8 week
Pittsburgh Sleep Quality Index
Time Frame: 8 week
The PSQI is a valid and consistent survey comprising of 19 questions to assess quality and amount of sleep and the existence of a sleep disorder and its level in the previous month. The scale was adapted into the Turkish language by Agargün et al. (1996). The scale consists of seven components that assess patients subjective sleep quality, sleep delay, use of sleeping medication and disfunction in daily activities. Each item scores in the range 0-3 points and the total score of the seven components gives the total PSQI score. The total score has a value between 0-21 and a high total score demonstrates a poor quality of sleep. A total PSQI score which is ≤5 indicates "good sleep", and a score which is >5 indicates "poor sleep"
8 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Sabahattin Zaim University

Investigators

  • Principal Investigator: Zülfünaz Ozer, Dr, Istanbul Sabahattin Zaim University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2017

Primary Completion (Actual)

June 15, 2018

Study Completion (Actual)

October 31, 2018

Study Registration Dates

First Submitted

November 21, 2019

First Submitted That Met QC Criteria

November 21, 2019

First Posted (Actual)

November 25, 2019

Study Record Updates

Last Update Posted (Actual)

November 25, 2019

Last Update Submitted That Met QC Criteria

November 21, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2017-314

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

after the article is published

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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