Infant Pain During Vaccination and Maternal Anxiety

Vaccine Reaction Clinical Trial

Official title:

The Effect of Two Different Methods on Infant Pain During Vaccination and Maternal Anxiety: A Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05598372
• Other study ID #: E-88012460-050.01.04-208074
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2022
• Est. completion date: December 22, 2023

Study information

• Verified date: October 2023
• Source: Ataturk University
• Contact: ARZU SARIALIOGLU, PHD
• Phone: 04422315795
• Email: arzu.celebi[@]atauni.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Type of Study The study was planned as a randomized controlled trial. Population and Sample 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.

Data Collection Tools Demographic Data Form, Neonatal Pain Scale and State Anxiety Scale 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.

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. He 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.

Data Collection Ethics and institutional permissions After the data is received, it will be explained to the participants that the confidentiality of the data will be protected, that personal information will not be requested, that the study is on a voluntary basis, and they will be informed that they can terminate the study at any time. Adolescents who agree to participate in the study will fill in the data collection form, which will take approximately 10 minutes, based on personal notification.

Experimental process In this study, it is planned to apply shotblocker and lullaby. Shotblocker application is not a drug application, it is a small apparatus that performs the blocking process on peripheral nerves to reduce the pain with protruding shape. There is no harm in the application. Another application planned in the study is lullaby. In this application, it is aimed to reduce the baby's pain, which is the painful process, by making the mother who is closest to the baby sing a lullaby. It is very important to compare these two methods. Namely; The effectiveness of two natural and artificial applications will be compared. The fact that this study has not been done before will also provide an important data source to the literature. The planned study will be conducted with 30 lullabies, 30 shotblockers, and 30 babies who come to Hocabey Family Health Center to receive their 6th month Hepatitis B dose and their mothers as a control group to help measure the effectiveness of these two groups. In order to reduce the variables in the application, the nurse who performed the application will be kept constant. For the preliminary application, the principal researcher will be at the center for 1 week and will make observations.

Analysis of the data The data will be evaluated as a result of statistical analyzes using the SPSS package program in computer environment. Descriptive statistics will be displayed as numbers, percentages, and mean±standard deviation. Skewness and Kurtosis values will be checked if the data is suitable for normal distribution. ±1.5 will be taken as the normal distribution limit value. Chi-square test, variance analysis and Pearson correlation analysis will be used in the analysis of the variables. Statistical significance level will be accepted as p˂0.05 in all analyzes.

Research Ethics During the collection of research data, the principle of informed consent, the principle of respect for autonomy and the protection of confidentiality and confidentiality will be followed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 22, 2023
• Est. primary completion date: December 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 6 Months

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Vaccine Reaction

Intervention

Behavioral:
• shotblocker
infant pain during vaccination and mother anxiety
• lullaby
infant pain during vaccination and mother anxiety

Locations

Country	Name	City	State
Turkey	Ataturk University Nursing of Faculty	Erzurum	Center

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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