Is foot reflexology effective in reducing acute pain of infants after vaccination?
Date of publication of the randomized controlled trial: October, 2015
Design
Randomized controlled trial (RCT).
Participants
60 infants aged between 1 month and 12 months, having a body weight of 2500 to 3500 grams, being born term and being developmentally normal according to Ankara Developmental Screening Inventory (ADSI) (mean age: 126.11 days, male %: 46.7%).
Intervention
Reflexology was performed before vaccine starting on the toes of one foot down to the heel; the same process was performed on the other foot. The treatment was conducted while the infant was in his or her mother’s arm to make the infant relax. Duration of treatment was 20 to 30 minutes on average according to the physical size of the infant’s feet.
Comparator
Comparison: Foot reflexology versus no intervention.
Major Outcomes
Outcome 1: Pain as measured by Face, Legs, Activity, Cry, Consolability (FLACC) Pain Assessment Scale after vaccination. Higher scores indicated higher levels of pain;
Outcome 2: Heart rates as measured by pulse oximeter after vaccination;
Outcome 3: Oxygen saturation level as measured by pulse oximeter after vaccination;
Outcome 4: Crying periods as assessed by an iPhone5 phone chronometer after vaccination.
Settings
This study was performed in an outpatient setting.
Comparison    Foot reflexology versus no intervention
Main Results
Compared to no intervention, foot reflexology resulted in significant reduction in acute pain scores (p <0.001) of infants after vaccination as assessed by FLACC. Besides, the infants in reflexology group also had significantly lower heart rates (p <0.001), higher oxygen saturation (p <0.001), and shorter crying periods (p <0.001).
Comparison: Foot reflexology versus no intervention in infants receiving vaccine
Outcomes (unit) No. of studies (Total number of participants) Mean score (SD) /No. of participants Heterogeneity test ( I2) MD (95% CI) p value Overall quality of evidence*
Intervention Comparator
1 (NA) 1 (60) 5.47 (2.11)/30 9.63 (0.85)/30 Not applicable as there is only 1 study. Not reported <0.001 Moderate
2 (NA) 1 (60) 136.43 (9.93)/30 148.50 (6.08)/30 Not applicable as there is only 1 study. Not reported <0.001 Moderate
3 (NA) 1 (60) 92.13 (2.96)/30 89.37 (1.00)/30 Not applicable as there is only 1 study. Not reported <0.001 Moderate
4 (s) 1 (60) 50.43 (31.19)/30 100.17 (29.68)/30 Not applicable as there is only 1 study. Not reported <0.001 Moderate
Keys: SD = standard deviation; CI = confidence interval; MD = mean difference.
Comparison    Foot reflexology versus no intervention
Main Results
Compared to no intervention, foot reflexology resulted in significant reduction in acute pain scores (p <0.001) of infants after vaccination as assessed by FLACC. Besides, the infants in reflexology group also had significantly lower heart rates (p <0.001), higher oxygen saturation (p <0.001), and shorter crying periods (p <0.001).
Comparison: Foot reflexology versus no intervention in infants receiving vaccine
Outcomes (unit) 1 (NA) 2 (NA) 3 (NA) 4 (s)
No. of studies (Total number of participants) 1 (60) 1 (60) 1 (60) 1 (60)
Mean score (SD) /No. of participants Intervention 5.47 (2.11)/30 136.43 (9.93)/30 92.13 (2.96)/30 50.43 (31.19)/30
Comparator 9.63 (0.85)/30 148.50 (6.08)/30 89.37 (1.00)/30 100.17 (29.68)/30
MD (95% CI) Not reported Not reported Not reported Not reported
p value <0.001 <0.001 <0.001 <0.001
Overall quality of evidence* Moderate Moderate Moderate Moderate
Keys: SD = standard deviation; CI = confidence interval; MD = mean difference.
Conclusion
Benefits
Compared to no intervention, foot reflexology before vaccine significantly reduced the pain level experienced by infants after vaccination. It also resulted in significant lower heart rates, higher oxygen saturation and shorted crying periods among infants. For all outcomes, the overall quality of evidence is moderate. Further research is fairly likely to have an important impact on our confidence in this estimate of effect.
Harms
The authors did not mention adverse events of the intervention.
Link to Original Article
https://www.ncbi.nlm.nih.gov/pubmed/26220257
The synopsis is based on the following article:
Koç T, Gözen D. The Effect of Foot Reflexology on Acute Pain in Infants: A Randomized Controlled Trial. Worldviews Evid Based Nurs. 2015 Oct;12(5):289-96.


* Interpretation of quality assessment results:
• Very low: Further research is most likely to have an important impact on our confidence in this estimate of effect.
• Low: Further research is likely to have an important impact on our confidence in this estimate of effect.
• Moderate: Further research is fairly likely to have an important impact on our confidence in this estimate of effect.
• High: Further research is unlikely to have an important impact on our confidence in this estimate of effect.
• Very high: Further research is most unlikely to have an important impact on our confidence in this estimate of effect.

Details of assessment method can be found at Chung VC, Wu XY, Ziea ET, Ng BF, Wong SY, Wu JC. Assessing internal validity of clinical evidence on effectiveness of CHinese and integrative medicine: Proposed framework for a CHinese and Integrative Medicine Evidence RAting System (CHIMERAS). European Journal of Integrative Medicine. 2015 Aug 31;7(4):332-41.