The Effect of Using Musical and Lighted Baby Crib Mobile on Newborns' Pain and Stress During Blood Draw

NCT ID: NCT06428929

Last Updated: 2024-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-04
• Study Completion Date: 2022-07-31

Brief Summary

It is widely recognized that the use of non-pharmacological methods in neonatal pain management is low both globally and in our country. Nurses play a crucial role in managing pain through various techniques and in preventing its negative effects on newborns. Toys with sounds, lights, and different features have been found to effectively capture infants' attention. Consequently, it is anticipated that baby crib mobiles, which combine these attention-grabbing features, could serve as effective distractions during needle interventions, potentially reducing pain and stress. However, there is a lack of research on this specific application.

Detailed Description

Newborns often undergo needle procedures shortly after birth, such as vitamin K injections, hepatitis B vaccinations, screenings, and routine immunizations. Depending on the baby's condition, these procedures may need to be repeated, and additional blood samples might be required. These painful procedures can cause significant stress for the newborn and may lead to neurocognitive, physiological, metabolic, and behavioral issues. Pain experienced during these procedures can negatively impact the newborn's future reactions to pain. Therefore, inadequate pain management can result in both immediate and long-term adverse effects.

Organizations such as the International Neuropsychiatric Pain Group and the American Academy of Pediatrics advocate for reducing pain in infants during procedures, recommending non-pharmacological methods as the first line of management. These methods, aimed at providing analgesic effects by creating a relaxing environment, are important because they do not have side effects. Some proven non-pharmacological techniques include breastfeeding, skin-to-skin contact, swaddling, music therapy, oral glucose, and pacifier use.

Music therapy is a widely used non-pharmacological method that helps reduce pain perception in newborns. Studies have shown its effectiveness in various settings. For instance, research with premature newborns found that music therapy during central venous catheter placement reduced physiological and behavioral reactions. Another study with 120 healthy newborns reported that having a musical baby crib mobile in vaccination rooms decreased pain levels and crying times. Other studies have similarly highlighted the positive effects of listening to or singing lullabies during painful procedures.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Control

Infants in the control group received standard care, with no pharmacological or non-pharmacological methods used to reduce pain, except for allowing the parents to be present. Parents and nurses observed the infant's behavior during and immediately after the procedure to assess pain and stress. After the procedure, they were asked to mark the maximum pain and stress experienced by the baby on the "ALPS-Neo pain and stress rating scale." This assessment was done immediately after the needle was removed and a tampon was placed to stop the bleeding, approximately one minute after the procedure.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

Before the procedure, the researcher informed the parents of the newborns in the musical and lighted baby crib mobile group about the study procedure and purpose. The mobile was fixed 60 cm above the newborn's eye level to prevent contamination and trauma. After obtaining written consent, the researcher collected data using the 'Newborn Information Form' through face-to-face interviews. Once the form was completed, the mobile was activated. One minute later, the nurse performed the blood draw. Parents and nurses observed the infant's behavior during and immediately after the procedure to assess pain and stress. They were then asked to mark the maximum pain and stress experienced by the baby on the ALPS-Neo pain and stress rating scale.

Group Type: EXPERIMENTAL

The musical and lighted baby crib mobile:

Intervention Type: OTHER

The musical and lighted baby crib mobile: It measures 43.5x33x9.5 cm and is made of plastic. It is recommended for use in infants 0-12 months. It has music that makes it easier for babies to fall asleep by reducing stress. This baby mobile has a projection and music function. In addition, the mobile has a 360° flexible swivel bracket that can be adjusted as desired. The surface of the apparatus of the mobile, which is designed to be environmentally and baby friendly, is smooth. There are four rattles on the mobile

Interventions

The musical and lighted baby crib mobile:

The musical and lighted baby crib mobile: It measures 43.5x33x9.5 cm and is made of plastic. It is recommended for use in infants 0-12 months. It has music that makes it easier for babies to fall asleep by reducing stress. This baby mobile has a projection and music function. In addition, the mobile has a 360° flexible swivel bracket that can be adjusted as desired. The surface of the apparatus of the mobile, which is designed to be environmentally and baby friendly, is smooth. There are four rattles on the mobile

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• born between 38-42 weeks,
• being 0-28 days,
• absence of visual and auditory problems,
• not using any pain reliever or sedative medication in the last four hours,
• parents' willingness to participate in the study,
• parents' knowledge of Turkish,
• parents' ability to read and write.

Exclusion Criteria

• having a preterm birth,
• having a disease that causes chronic pain,
• having visual or auditory problems,
• using any pain or sedative medication in the last four hours.

• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Koç University

OTHER

Sponsor Role: lead

Responsible Party

Eysan Hanzade Umac

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eyşan Savaş, PhD

Role: PRINCIPAL_INVESTIGATOR

Koç University

Locations

Koc University

Istanbul, Zeytinburnu, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

EysanUmac

Identifier Type: -

Identifier Source: org_study_id