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

NCT04175652 | Completed DMC

• 1 other identifier: 2017-314
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Laughter Yoga; Hemodialysis Patients

Keywords

Laughter Yoga; Hemodialysis; Pain; Sleep; Beta Endorphin

Outcome Measures

Primary Outcomes (3)

• Beta-endorphin Level

  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

  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

  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

Study Arms (2)

Laughter yoga group, group doing laughter yoga

EXPERIMENTAL

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

No laughter yoga group, group not doing laughter yoga

NO INTERVENTION

Interventions

Laughter yoga BEHAVIORAL

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.

Laughter yoga group, group doing laughter yoga

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Sabahattin Zaim University: lead

Study Sites (1)

Istanbul Sabahattin Zaim University, Faculty of Health Sciences

Istanbul, Küçükçekmece, 34303, Turkey (Türkiye)

Location

Related Publications (2)

• Heo EH, Kim S, Park HJ, Kil SY. The effects of a simulated laughter programme on mood, cortisol levels, and health-related quality of life among haemodialysis patients. Complement Ther Clin Pract. 2016 Nov;25:1-7. doi: 10.1016/j.ctcp.2016.07.001. Epub 2016 Jul 27.

  PMID: 27863598 BACKGROUND

• Yim J. Therapeutic Benefits of Laughter in Mental Health: A Theoretical Review. Tohoku J Exp Med. 2016 Jul;239(3):243-9. doi: 10.1620/tjem.239.243.

  PMID: 27439375 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics

Study Officials

• Zülfünaz Ozer, Dr

  Istanbul Sabahattin Zaim University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD., Assistant Prof.

Model Details: Parallel Assignment Randomization; participants were divided into two groups by using simple random numbers table, and then the first group which was drawn by lot method was named as the experimental group.

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 25, 2019
• Study Start: November 15, 2017
• Primary Completion: June 15, 2018
• Study Completion: October 31, 2018
• Last Updated: November 25, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)