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Efficacy of Manual Pressure in Infants

NCT05143450 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-06-15

No results posted yet for this study

Summary

Manual pressure is an effective, easy-to-apply, no preparation, and cost-effective method of reducing pain associated with the injection. This study will be carried out to determine the effect of manual pressure applied to the injection site on the pain level and crying time of the infants before the injection of the Diphtheria-Tetanus-Acellular Pertussis Vaccine (DTaP), Inactivated Polio Vaccine (IPV), and Haemophilus Influenzae Type b Vaccine (Hib) (5-in-1) in 2-month-old infants. The study will be conducted with the randomized controlled experimental method. Before the procedure, manual pressure will be applied to the injection site with the thumb for 10 seconds to the infants in the experimental group. No non-pharmacological method will be used before vaccination to the infants in the control group. Pain scores of infants in the intervention and control groups will be evaluated before, during, and after vaccination. In addition, the total crying times of the babies will be calculated and recorded with a stopwatch.

Conditions

  • Pain Management

Interventions

OTHER

Manual Pressure

In the experimental group manual pressure will be applied to the injection site with the thumb for 10 seconds to the infants by the researcher before the procedure. Manual pressure reduces pain within the framework of the gate control theory. According to the gate control theory, when pressure is applied to an area, a fiber transmits the feeling of pressure instead of pain and ultimately the pain sensation is alleviated.

Sponsors & Collaborators

  • Biruni University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Months
Max Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-15
Primary Completion
2022-06-02
Completion
2022-06-02

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05143450 on ClinicalTrials.gov