Study design and participants
Diabetes
TYPE 2 DIABETES, DIABETES
This study was a single-center, two-group, randomized controlled trial designed to evaluate the effects of laughter yoga on individuals with type 2 diabetes. The intervention was conducted at Osaka University from October 2015 to December 2015. The study protocol was approved by the Scientific Ethics Committee of Fukushima Medical University (no. 2028). The Declaration of Helsinki was followed, and reporting in this article is aligned with the Consolidated Standards of Reporting Trials standards. All participants provided oral and written informed consent. This trial was registered at the University Hospital Medical Information Network Clinical Trials Registry (no. UMIN000047164).Participants were recruited at the Diabetes Center of Osaka University Hospital, between August 2015 and September 2015. Three diabetologists evaluated their outpatients for study eligibility and approached patients meeting the eligibility criteria. Eligible patients received a flyer and the study was explained. Patients were recruited in order of their visit until the number of participants reached the target sample size. The inclusion criteria were outpatients aged 40 years or older with type 2 diabetes, HbA1c levels ranging from 6.1% to 7.9%, and changes in HbA1c levels < 1.0% during the last 3 months before baseline measurements. The glycemic control target is set at HbA1c <7.0% in Japan and modification of treatment (including intensive pharmacotherapy or insulin treatment) is needed when HbA1c level exceeded 8% (Before randomization, the participants were informed that similar laughter yoga sessions would be held after the study period for those who were allocated to the control group to reduce the reporting bias.