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Survey the Effect of Foot Reflexology on Physiological Indices, Pain Level and Crying of Infants under Vaccination

Survey the Effect of Foot Reflexology on Physiological Indices, Pain Level and Crying of Infants under Vaccination

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20130412012990N10
Enrollment
90
Registered
2019-06-15
Start date
2019-06-22
Completion date
Unknown
Last updated
2019-08-26

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

Conditions

Physiological and behavioral indices of pain, duration of crying. Encounter for routine child health examination

Interventions

Intervention 1: Intervention group: The intervention will be carried out by the researcher who holds the reflexology certificate.The intervention method will be used by the researcher to wash his hand

Sponsors

Rasht University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Months to 7 Months

Inclusion criteria

Inclusion criteria: Age 2 to 7 months Being in a normal percentile of weight and height when receiving vaccine was born term (38-42 weeks gestation) to be calm and not crying before vaccination Body temperature between 36- 37. 2° C

Exclusion criteria

Exclusion criteria: Not taking acetaminophen or any other analgesic 3 hours before vaccination Not having a history of hospitalization Lack of diseases such as thyroid disorders, epilepsy, cardiovascular disease and acute diseases that reduces the level of consciousness of the child. Not having bad sleep or sleeplessness before vaccination

Design outcomes

Primary

MeasureTime frame
Pain level in the FLACC behavioral checklist. Timepoint: At first,the level of infant's pain in three groups of intervention, sham and control for one minute before massage is measured and recorded.Then massage performed for each group(Massage at the relevant points in the intervention group and neutral massage in the sham group).After this stage, the pain level will be measured and recorded for one minute in each of the three intervention, sham and control groups before the painful stimulus (after massage) and during painful stimulation (vaccine injection). Method of measurement: Using the FLACC scale (Face, Leg, Activity, Cry, Consolability), an appropriate tool for assessing pain-related behaviors in children ages 2 months to 7 years.This scale has 5 sections and examines the severity of pain through face reactions, leg positions,activity , crying and consolability.Each of these sections gives a score of 0 to 2, which ultimately brings together scores. Based on the overall score, zero score means no pain and 10 means the sharpest pain level.The overall score is divided into three levels: score 0 to 3 represents a reduction in pain, 4 to 7 represents moderate pain, and 7 to 10 means severe pain.

Secondary

MeasureTime frame
Mean score of physiological indices(Heart rate, Arterial blood oxygen saturation), average crying time. Timepoint: At first, the physiological indices of infants in three groups of intervention, sham and control by pulse oximeter are measured and recorded for one minute before massage.Massage will then be performed for each group (massage at the relevant points in the intervention group and neutral area massage in the sham group).After this stage, physiological indices for one minute will be measured and recorded in each of the three intervention, sham and control groups before the painful stimulus (after massage) and during the acute stimulus (vaccine injection) are performed. Method of measurement: To measure physiological indices (arterial blood oxygen saturation, heart rate), a child finger pulse oximeter ,The brand Zyklusmed, will be used with China's CMS 50 QB code.The Galaxy J7 Pro SM-J730F stopwatch will be used to measure infant crying time.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParichehr Shahroudi Tamrin

Rasht University of Medical Sciences

parichehr.shahroudi@gmail.com+98 13 3355 2418

Outcome results

None listed

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