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. 2023 Oct 24;2023(10):CD014722. doi: 10.1002/14651858.CD014722.pub2

Bernardi 2020.

Study characteristics
Methods Study design: RCT
Duration of study: the study was conducted from September 2016 to September 2017.
Country: Brazil
Income classification: upper‐middle‐income country in 2016‐2017
Geographical scope: city of Vitória, state of Espírito Santo, Southeastern Brazil
Healthcare setting: Children's Hospital of the Great Vitória area: Hospital Infantil Nossa Senhora da Glória (HINSG)
Participants 1. Age: participants' age group varied between 18 and 50 years, with the majority being aged 31 to 40 years (44%)
2. Gender: both
3. Socioeconomic background: NA
4. Educational background: all the participants had some level of schooling, and 58% attended school for more than 9 years.
Inclusion criteria—children:
children and adolescents undergoing cancer treatment.
Inclusion criteria—caregivers:
caregivers of:
a. children and adolescents admitted to HINSG as new cases of cancer for treatment older than 18 years;
b. accompanied the children or adolescents for a minimum period of 40 hours per week;
c. had never had previous contact with yoga, meditation or similar techniques.
Exclusion criteria:
a. hospitalizations or deaths over very short periods, which prevented us from inviting the caregiver to participate in the study;
b. hospitalizations in which the patient's clinical condition was already in an advanced and irreversible state, that is, the patient was on palliative care;
c. cases in which the volunteer had previous knowledge of the patient's diagnosis.
Note: at baseline, the intervention and control group scores for the State‐Trait Anxiety Inventory (STAI) were, respectively, 54.8 (10.6) and 54.3 (9.4).
Stated purpose: to investigate the effects of the Hatha Yoga intervention on levels of anxiety, subjective well‐being, mindfulness, and awareness of caregivers of children and adolescents undergoing cancer treatment
Interventions Name: Hatha Yoga
Title/name of PW and number: qualified Hatha‐Yoga instructor (1)
1. Selection: not specified
2. Educational background: not specified
3. Training: not applicable
4. Supervision: not applicable
5. Incentives/remuneration: not specified
Prevention type: indicated prevention – participants of the clinical and control groups presented some levels of anxiety as indicated by STAI scores, and they were included based upon the presence of a risk factor (being caregivers of children and adolescents undergoing cancer treatment).
Intervention details: Hatha Yoga, its main branch in the Western world, uses body poses, breathing exercises, relaxation and meditation with the purpose of self‐perception and self‐knowledge, which assists individuals in their physical, psychological, spiritual and social dimensions.
Control: usual care (routine of care provision for the children/adolescents without participating in the intervention)
Outcomes Participants’outcomes of interest for this review
  1. Anxiety symptoms – STAI

  2. Quality of life – Positive Satisfaction with Life of the Subjective Well‐Being Scale (EBES)

  3. Psychological functioning and impairment – Problem Focused Coping Subscale of the Ways of Coping Scale (EMEP)

  4. Social outcomes – Seeking Social Support Subscale of the Ways of Coping Scale (EMEP)


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): the STAI is validated widely across contexts; translation and validation were not reported for this sample. The EBES and EMEP questionnaires had cultural validation.
Additional information: none
Handling the data: not applicable
Prospective trial registration number: Brazilian Clinical Trials Registry, protocol RBR‐3vz3nd