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The effect of reflexology on breast milk of women with premature hospitalized newborns

The effect of reflexology on breast milk of women with premature hospitalized newborns: a randomized control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201501073706N24
Enrollment
74
Registered
2015-03-05
Start date
2015-03-06
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Breast feeding. Feeding problems of newborn

Interventions

Intervention 1: Intervention group: reflexology on the breast, solar plexus and pituitary points on the feet for 20 minutes (10 minutes on each foot), once a day for seven days. Intervention 2: contro
Rehabilitation
Intervention group: reflexology on the breast, solar plexus and pituitary points on the feet for 20 minutes (10 minutes on each foot), once a day for seven days
control group: reflexology on the eye, shoulder and back points of feet for 20 minutes (10 minutes for each foot) once a day for seven days

Sponsors

Research deputy of Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: lactating women who have a singleton or twin preterm infant (s) (gestational age of 28.0 to 37.0 weeks) aged 7-60 days hospitalized at the neonatal unit or neonatal intensive care unit; have willing to continue breastfeeding; have 30% or more decreased milk supply compared to the peak volume (based on maternal account) or have inability to provide adequate breast milk to meet infant nutritional needs and a neonatologist confirms the insufficient milk production; have permanent or temporary stay at the hospital during the seven days of intervention. Exclusion criteria: metabolic diseases in the infant (s); infection or sore of woman's feet; chronic systemic illness of the woman; inability to fill up the self-administered questionnaire; no Iranian nationality; occurrence of severe psychological problems for the woman such as death of a close relative in the previous 3 months; and intention to start using a drug which may have an effect on the milk production (e.g. metoclopramide, domperidone) or change dose of the drugs in the next 15 days

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
The volume of milk expressed 2 hours after the last expression and at least half an hour after the massage. Timepoint: Before intervention - on the first, fourth and seventh days of intervention. Method of measurement: Squeezing through the electric pump.;Volume of breast milk expressed during 24 hours. Timepoint: Before intervention- on the first, fourth and seventh days of intervention. Method of measurement: recording on the diary by the women.

Secondary

MeasureTime frame
Volume of breast milk substitutions given to the infant during 24 hours. Timepoint: Before intervention, on the first, fourth, and seventh days intervention. Method of measurement: using nursing report.;Infant weight gain. Timepoint: before intervention- on the first, fourth and seventh intervention days. Method of measurement: newborn weighting scale with a precision of one gram.;The infant's heart rate. Timepoint: before intervention, ?n the first, fourth and seventh intervention days. Method of measurement: Pulse oximeter.;Infant oxygen saturation. Timepoint: before intervention, on the first, fourth, seventh intervention days. Method of measurement: Pulse oximeter.;Depression score of the women. Timepoint: Before intervention, the seventh day of intervention. Method of measurement: Through self-report questionnaire DASS.;Anxiety score of the women. Timepoint: Before intervention, the seventh day of intervention. Method of measurement: ?? ???? ???????? ??? ?????? DASS.;Stress score of the women. Timepoint: Before intervention, the seventh day of intervention. Method of measurement: Through self-report questionnaire DASS.;The proportion of infant feeding with expressed breast milk. Timepoint: seventh day of intervention. Method of measurement: The women report table and nursing reports in the infant record.;Exclusive breastfeeding. Timepoint: seventh day of Intervention. Method of measurement: Nursing report and woman report.;Woman satisfaction of the intervention. Timepoint: seventh day of intervention. Method of measurement: woman report.;Woman satisfaction from breastfeeding. Timepoint: the seventh day of Intervention, Seven days after end of intervention. Method of measurement: woman report.;Occurrence of adverse events. Timepoint: During the study. Method of measurement: woman report.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParisa Mirzaee

Tabriz University of Medical Sciences, Nursing & Midwifery Faculty

yoosefe.zahra@yahoo.com+98 41 3544 6210

Outcome results

None listed

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