The effect of Vimala massage on stress hormone levels in the saliva of premature babies
| ISRCTN | ISRCTN75126874 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75126874 |
- Submission date
- 25/03/2022
- Registration date
- 29/03/2022
- Last edited
- 28/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Plain English summary of protocol
Background and study aims
In neonatal intensive care units across the world, premature babies are exposed to a very stressful environment with high levels of noise, bright lights, pain, infections, invasive procedures, and a lack of maternal contact. Massage has been reported to be associated with decreased levels of stress, cortisol and with increased oxytocin levels. The aim of this study is to assess the impact of Vimala massage on salivary cortisol levels, clinical signs of stress and growth in premature babies admitted to a neonatal intensive care unit.
Who can participate?
Premature babies (28-36 weeks gestational age) admitted to a nursery unit
What does the study involve?
Participants are randomly allocated to receive 15-20 minutes of Vimala massage administered by their parents twice daily and usual care, or to receive usual care only. Salivary cortisol levels are measured on days 1 and 5. Heart rate, breathing rate, calorie intake, weight gain and growth are recorded daily.
What are the possible benefits and risks of participating?
The possible benefits of participating are lower cortisol levels and stability of clinical signs of stress. The risks of participating are possible discomfort from massage.
Where is the study run from?
High Specialty Medical Unit No 48, Mexican Institute of Social Security (Mexico)
When is the study starting and how long is it expected to run for?
March 2015 to February 2016
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dra Alma Patricia González
patipili999@hotmail.com
Contact information
Principal Investigator
Av México e insurgentes s/N
col. Los paraísos
Leon
37296
Mexico
 ORCID ID |
0000-0002-3401-7519 |
|---|---|
| Phone | +52 (0)4771329126 |
| patipili999@hotmail.com |
Scientific
Av México e insurgentes s/N
col. Los paraísos
Leon
37328
Mexico
| ORCID ID |
0000-0002-8460-4965 |
|---|---|
| Phone | +52 (0)477 393 14 26 |
| patriciasb@hotmail.com |
Study information
| Study design | Single-center interventional blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Salivary cortisol in premature neonates treated with Vimala massage: a randomized controlled trial |
| Study objectives | Vimala massage impacts the salivary cortisol levels, clinical signs of stress and growth in premature neonates admitted to a neonatal intensive care unit |
| Ethics approval(s) | Approved 19/08/2015, Local Health Research Committee 1002 (México e Insurgentes Av. León Gto. México. +52 (0)477 7174800 ext 31804; investigaUMAE48@gmail.com), ref: R-2015-1002-29 |
| Health condition(s) or problem(s) studied | Perinatal health |
| Intervention | After consent, patients are randomized 1:1 to receive usual nursing care plus Vimala massage (intervention) or usual nursing care alone (control). In the intervention group, parents receive a 20-minute individual session with their child, where they are shown the massage techniques to use and given a printed booklet illustrating the different positions and movements. Parents are then asked to demonstrate the massage maneuvers and demonstrate proficiency in at least 80% of the massage components. The massage is performed by the parents under moderate pressure twice a day for 15-20 minutes on five consecutive days, at 12:00 and 18:00 under the supervision of one of the researchers. A saliva sample is collected 1 hour before the first day of massage and after 5 days of massage, and at equivalent time points in control infants. Samples are collected between 11:00 and 12:00 and newborns must fast for at least 1 hour before sampling. To stimulate saliva production, two drops of 30% glucose solution are placed on the infants' tongue before the sample was obtained. After oral inspection to ensure there is no milk contamination, a plastic Pasteur pipette is placed inside the cheek to collect the sample. The sample is immediately transferred to plastic test tubes and transported to the laboratory where it is stored at -20°C. Cortisol is measured using the DRG Salivary Cortisol by ELISA test (DRG Instruments GmbH, Marburg, Germany). The test has detection limits of 0.0537 to 8 micrograms per deciliter with an inter-assay variation of 7.47% and an intra-assay variation of 2.65%. |
| Intervention type | Behavioural |
| Primary outcome measure | Salivary cortisol measured using the DRG Salivary Cortisol by ELISA test (DRG Instruments GmbH, Marburg, Germany) 1 hour before the first day of massage and after 5 days of massage, and at equivalent timepoints in control infants |
| Secondary outcome measures | 1. Heart rate, respiratory rate, and oxygen saturation measured with a Choice brand model MMED 600DP vital signs monitor with saturation sensor in the right hand for five consecutive days between 7:00 and 8:00 am 2. Weight measured with a digital scale Se GmbH & Co. Kg model 374 1321009 (Hamburg, Germany) for five consecutive days at 8:00 am 3. Length measured with a non-elastic anthropometric tape, Seca 201® for five consecutive days at 8:00 am |
| Overall study start date | 01/03/2015 |
| Completion date | 28/02/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 70 |
| Total final enrolment | 72 |
| Key inclusion criteria | 1. Premature neonates born by caesarean section or vaginal delivery 2. 28-36 weeks of gestational age (Ballard scale) 3. Admitted to the nursery unit 4. Fed by mouth 5. Hemodynamically stable 6. Required no respiratory support 7. Unremarkable physical examination 8. A parent (mother or father) had to be available and willing to provide massage to the neonate |
| Key exclusion criteria | Patients with active infections |
| Date of first enrolment | 30/09/2015 |
| Date of final enrolment | 30/12/2015 |
Locations
Countries of recruitment
- Mexico
Study participating centre
col. Los paraísos
León Guanajuato
37328
Mexico
Sponsor information
Hospital/treatment centre
Av México e insurgentes s/N
col. Los paraísos
Leon
37328
Mexico
| Phone | +52 (0)477 7174800 ext 31804 |
|---|---|
| investigaumae48@gmail.com |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 30/05/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
28/03/2022: Trial's existence confirmed by the Local Health Research Committee 1002.
