Reiki practice and the quality of life of diabetic pregnant women
| ISRCTN | ISRCTN69018802 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69018802 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | CAAE 52734216.1.0000.5411 |
| Sponsor | São Paulo State University |
| Funder | Investigator initiated and funded |
- Submission date
- 01/08/2021
- Registration date
- 02/08/2021
- Last edited
- 12/04/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Women may get a type of diabetes that only happens in pregnancy. This is called gestational diabetes. Pregnancy can change how a woman's body uses glucose. This can make diabetes worse, or lead to gestational diabetes.
Reiki, a non-drug treatment used on people suffering from anxiety, depression, or both, appears to be an intriguing approach to treating the psychological impact of a woman's response to a diagnosis of gestational diabetes. However, randomized controlled trials comparing various Reiki strategies are required. The purpose of this trial is to analyse if the therapeutic modality of laying on of hands (Reiki) delivered by a trained Reiki practitioner, either face-to-face or remotely, was more effective than Sham-Reiki in controlling anxiety and depression in pregnant women with gestational diabetes.
Who can participate?
Pregnant women with hyperglycaemia.
What does the study involve?
The participants were randomized to Face-to-Face Reiki, Remote Reiki, or Sham-Reiki. Changes in the World Health Organization Quality of Life questionnaire, Beck depression inventory and Beck State-Trait anxiety surveys were the primary outcomes after 7 full Reiki sessions by applying standardized and validated surveys in Portuguese.
What are the possible benefits and risks of participating?
Benefits are related to the improvement of quality of life as well as lowering the levels of depression and anxiety, in addition to have a holistic approach throughout prenatal care. There are no risks involved, since the Sham group continued to receive the medical and nursing care as all the groups. The only difference is that two groups received genuine Reiki while the other not.
Where is the study run from?
Botuctu Medical School (Brazil)
When is the study starting and how long is it expected to run for?
March 2016 to March 2019
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Guilherme Ferraz, guilhermerago@hotmail.com
Contact information
Scientific
2902 Universitária Avenue
Altos do Paraíso
Botucatu
18610034
Brazil
 ORCID ID |
0000-0001-6596-8782 |
|---|---|
| Phone | +55 14 981746951 |
| guilherme.rago@unesp.br |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blinded randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Reiki practice and the quality of life of diabetic pregnant women: a randomized clinical trial |
| Study objectives | The aim of this study was to determine whether the therapeutic modality of laying on of hands (Reiki) may enhance the quality of life, as well as reducing depression and anxiety levels in hyperglycaemic pregnant women |
| Ethics approval(s) | Approved 07/03/2016, Institutional Research Bureau of Botucatu Medical School, UNESP (Chacára Butignoli s/n, Rubião Júnior. Botucatu, State of São Paulo, 18618-970, Brazil; +55 14 3880-1609; cep.fmb@unesp.br), ref: CAAE 52734216.1.0000.5411 |
| Health condition(s) or problem(s) studied | Depression and anxiety levels in hyperglycaemic pregnant women |
| Intervention | Patients were allocated at random by the chief nurse into one of the three groups Sham, Face-to-Face or Remote Reiki at PDRC/HC FMB. Randomization was carried out by the Research Support Office (EAP) of FMB/UNESP using verified software, which is available on the website www.randomization.com. The participants and those evaluating the outcomes were all blinded. The control or intervention groups were only known to the Reiki therapist and Reiki simulation researchers. The Face-to-Face intervention group had 7 sessions throughout prenatal care. The lead researcher is a licensed Reiki Master and has expertise with Reiki Therapy and has personally carried out the sessions with the approval of the pregnant person by a free explanation of permission and signed informed consent form. Reiki treatments were arranged on the same day as the pregnant woman's outpatient appointment, lasting 30 minutes each. The Remote intervention group also had 7 sessions, which were also carried by the lead author. The remote treatments were planned on the same day that the pregnant woman returned for her outpatient visit, but without her presence, and lasted 30 minutes each session. In the control group, participants received a simulation of laying on of hands, the hands' position used in the simulation was the same as the intervention group. This placebo was carried out by another research member who had been trained to imitate the session using the identical touch motions as the intervention group but had neither previous knowledge of Reiki nor competence. In the end, Sham Reiki replicated the identical technique as Face-to-Face Reiki therapy; however, only the researchers who used genuine and sham Reiki knew, and the patients had no idea who was in the control or intervention groups. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Measured at baseline and after 7 sessions: |
| Key secondary outcome measure(s) |
Glycaemic profile measured by blood tests taken throughout pregnancy |
| Completion date | 20/03/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 150 |
| Total final enrolment | 134 |
| Key inclusion criteria | 1. Pregnant women 2. Fasting glucose 92 mg/dl and/or a risk factor for diabetes 3. Positive screening for Gestational Diabetes Mellitus (GDM), with the diagnosis made by the 75g oral glucose tolerance test (GTT) and glycaemic profile (GP). |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 08/03/2016 |
| Date of final enrolment | 20/12/2018 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Distrito de Rubião Júnior
Botucatu
18618-687
Brazil
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request (guilhermerago@hotmail.com). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 02/06/2021 | 02/08/2021 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Thesis results | 27/08/2021 | 12/04/2022 | No | No |
Editorial Notes
12/04/2022: Thesis link added.
02/08/2021: Trial's existence confirmed by Institutional Research Bureau of Botucatu Medical School, UNESP.
