Efficacy of Manual Pressure in Infants

NCT05143450 | Completed

• 1 other identifier: 2015-KAEK-53-21-02
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

injection; manual pressure; pain; pain management; vaccination

Outcome Measures

Primary Outcomes (1)

• Change of Pain

  Pain will assess by the healthcare provider who performs the venipuncture procedure with the FLACC (Face, Legs, Activity, Cry, Consolability) Scale. This scale was developed to evaluate the pain of children aged 2 months to 7 years. The child's facial expression, leg movements, activity, crying, and comfortability behaviors are evaluated in relation to pain. These five behaviors are rated with 0, 1, or 2 points. The total score of the scale ranges from 0 to 10, and a high score indicates that the child has more pain. '0' points from the scale indicate no pain, '1-3' points indicate mild pain, '4-6' points indicate moderate pain, and '7-10' points indicate severe pain.

  Before vaccine injection, when the vaccine starts to be injected and immediately after the injector was removed.

Secondary Outcomes (1)

• Crying time

  During vaccine injection and immediately after injection

Study Arms (2)

Experimental Group

EXPERIMENTAL

Before the procedure, manual pressure will be applied to the injection site with the thumb for 10 seconds to the infants by the researcher.

Other: Manual Pressure

Control Group

NO INTERVENTION

No intervention will perform to reduce pain in the control group.

Interventions

Manual Pressure OTHER

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.

Experimental Group

Eligibility Criteria

• Age: 4 Months - 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Being a healthy baby born at term
• Being 4 months old
• Having no chronic disease,
• Having no neurological disease.
• Not taking an analgesic drug within 24 hours before vaccination.

You may not qualify if:

• Being an unhealthy baby born at preterm or post-term,
• Being younger or older than 4 months old,
• Having a chronic disease,
• Having a neurological disease,
• Taking an analgesic drug within 24 hours before vaccination.

Sponsors & Collaborators

• Biruni University: lead

Study Sites (1)

Kumkapi Family Health Center

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia; Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, PhD

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: December 3, 2021
• Study Start: December 15, 2021
• Primary Completion: June 2, 2022
• Study Completion: June 2, 2022
• Last Updated: June 15, 2022

Record last verified: 2021-11

Locations

TU (1)