Izgu 2020.
| Study characteristics | |
| Methods |
Study design: RCT Duration of study: the study was conducted from June 2018 to September 2019. Country: Turkey Income classification: upper‐middle income country in 2018‐2019 Geographical scope: Ankara, Turkey Healthcare setting: endocrine outpatient unit of Ankara University Medical Faculty, Ibn‐i Sina Hospital |
| Participants | 1. Age: mean age of participants was 64.2 ± 8.1 years in the relaxation group (RG), 61.6 ± 8.0 years in the meditation group (MG), and 64.1± 6.6 years in the control group (CG). 2. Gender: both 3. Socioeconomic background: not specified 4. Educational background: most of participants had at least graduated from primary school (RG = 60%, MG = 78.3%, CG = 73.9%). Inclusion criteria: a. diagnosed with DPNP; b. at least primary school graduates; c. not using any other complementary or integrative therapy during the study period. Exclusion criteria: a. neuropathy history due to any other causes such as megaloblastic anaemia, fibromyalgia, autoimmune diseases, hypothyroidism, and lumbar disc hernia; b. having end‐stage renal failure, chronic obstructive pulmonary disease, advanced cardiac failure, musculoskeletal disorders, or depression; c. having a diabetic foot ulcer or amputation. Note: at baseline, the intervention and control group scores for OUTCOME NAME were, respectively, MEAN (SD) and MEAN (SD). Stated purpose: to examine the effects of progressive muscle relaxation and mindfulness meditation on the severity of diabetic peripheral neuropathic pain (DPNP), fatigue, and quality of life in patients with type 2 diabetes |
| Interventions |
Name: intervention 1—MG intervention 2—RG Title/name of PW and number: 1 trained nurse (third co‐author, research assistant at the Internal Medicine Nursing Department) 1. Selection: not specified 2. Educational background: certified and experienced in progressive muscle relaxation and mindfulness meditation 3. Training: not specified 4. Supervision: not specified 5. Incentives/remuneration: not specified Prevention type: selective—participants were included based upon the presence of a risk factor (being type 2 diabetes patients). Intervention details Intervention 1—MG: a sitting mindfulness meditation, as a part of the mindfulness‐based stress reduction (MBSR) programme, was used. Each daily session lasted for 20 min, with thoughts focusing on deep breathing and the present moment. Intervention 2—RG: the progressive muscle relaxation sessions were performed following the steps of the progressive muscle relaxation programme designed by Jacobson 1938. Each daily session lasted for 20 min, during which participants were instructed about tensing and relaxing the body muscles, along with deep breathing. The patients practised daily progressive muscle relaxation, beginning with the muscles of the face and head, followed by those of the neck, shoulders, hands, chest, abdomen, legs, and feet. For both MG and RG: face‐to‐face sessions of progressive muscle relaxation and mindfulness meditation training were provided by using training booklets. After these theoretical sessions, which lasted for 30 min, all progressive muscle relaxation and mindfulness meditation steps were practised by the participants under the supervision of the third co‐author for 20 min. Training sessions for the RG and MG were undertaken only once in a silent patient training room of the endocrine outpatient unit. Patients in the RG or MG practised these interventions once daily for 20 min for a total of 12 weeks. Control: usual care (patients in the CG received an attention‐matched control education session only once, in the same patient training room) |
| Outcomes |
Participants’outcomes of interest for this review
Carers’ outcomes of interest for this review Nil Economic outcomes Nil Time points: baseline, post‐intervention (< 1 month) |
| Notes |
Source of funding: not specified Notes on validation of instruments (screening and outcomes): for NEPIQOL, in the Turkish validity and reliability study, the Cronbach’s alpha value was reported as 0.95, while in the current study it was calculated as 0.85. Additional information: none Handling the data: not applicable Prospective trial registration number: NCT04287439 |