Infant Pain During Vaccination and Maternal Anxiety

NCT05598372 | Completed

• 1 other identifier: E-88012460-050.01.04-208074
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This research was planned to determine the effect of two different methods on infant pain during vaccination and mother anxiety.The study was planned as a randomized controlled trial. The universe of this research consists of parents and their babies who come to Hocabey Family Health Center in Erzincan Center to receive the hepatitis B dose between these dates according to the vaccination calendar. In this study, it is planned to apply shotblocker and lullaby.

Conditions

Vaccine Reaction

Outcome Measures

Primary Outcomes (2)

• Newborn Infant Pain Scale (NIPS)

  The scale used in the assessment of newborn pain consists of 6 categories. It was developed in 1993 and its validity and reliability in our country was made in 1999. The score obtained from the scale varies between 0-7. Scale ; It consists of five behavioral indicators including facial expression, arm movement, leg movement, crying, alertness, and a physiological indicator that includes breathing.

  9 MONTHS

• State Anxiety Inventory

  The State Anxiety Scale was developed in 1970, and its Turkish validity and reliability study in our country was conducted in 1994. There are a total of 40 statements in the scale. The first twenty items measure the level of anxiety related to the situation, and each statement is "Not at all" (1), "Somewhat" (2), "Very"(3), "Totally"(4). Reverse coded items; Items 1, 2, 5, 8, 10, 11, 15, 16, 19, 20. Points are added and subtracted according to the reverse and direct coded items in the scale. She states that 0-19 points obtained from the scale mean no anxiety, 20-39 points mean mild, 40-59 points mean moderate, 60-79 points mean severe anxiety, and individuals with a score of 60 and above need professional help.

  9 MONTHS

Study Arms (3)

shotblocker

EXPERIMENTAL

infant pain during vaccination and mother anxiety

Behavioral: shotblocker

lullaby

EXPERIMENTAL

infant pain during vaccination and mother anxiety

Behavioral: lullaby

CONTROL

NO INTERVENTION

not infant pain during vaccination and mother anxiety

Interventions

shotblocker BEHAVIORAL

infant pain during vaccination and mother anxiety

shotblocker

lullaby BEHAVIORAL

infant pain during vaccination and mother anxiety

lullaby

Eligibility Criteria

• Age: 1 Month - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The child does not have a disorder in the cognitive developmental area.
• It is time to apply the hepatitis B vaccine of the 6th month.
• Parent giving consent to participate in the study voluntarily and for their child to participate.

You may not qualify if:

• The child has a disorder in the cognitive developmental area.
• Failure to apply the 6th month hepatitis B vaccine.
• Parent's voluntarily participating in the study and not giving consent for the child's participation.

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University Nursing of Faculty

Erzurum, Center, 25240, Turkey (Türkiye)

Location

Study Officials

• ARZU SARIALİOĞLU, PHD

  Ataturk University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: October 28, 2022
• Study Start: October 25, 2022
• Primary Completion: December 13, 2023
• Study Completion: December 22, 2024
• Last Updated: March 17, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)