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The effect of Vimala massage on stress hormone levels in the saliva of premature babies

Salivary cortisol in premature neonates treated with Vimala massage: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN75126874
Enrollment
70
Registered
2022-03-29
Start date
2015-09-30
Completion date
Unknown
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perinatal health Neonatal Diseases

Interventions

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-minut

Sponsors

Gynecology and Pediatric Hospital Number 48 of the Mexican Institute of Social Security
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Patients with active infections

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Mexico

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026