Pain and Comfort Level During Orogastric Catheter Insertion in Preterms

NCT ID: NCT06222047

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-12-30

Brief Summary

Purpose of the research:

This research was planned to evaluate the effect of breast milk and dextrose application, which are pain relief methods, on the pain and comfort levels of preterm babies who will have an orogastric tube inserted in the 3rd and 4th levels of the Neonatal Intensive Care Unit.

Hypotheses:

H0: The methods used during orogastric tube insertion do not affect the pain and comfort levels of preterm babies.

H1: Preterm babies who are breastfed feel less pain during orogastric tube insertion.

H2: Preterm babies given dextrose during orogastric tube insertion feel less pain.

H3: The comfort level of preterm babies who are breastfed during orogastric tube insertion is higher.

H4: The comfort level of preterm babies given dextrose during orogastric tube insertion is higher.

H5: There is a difference between the pain and comfort levels of preterm patients in terms of group, time, and group-time, depending on the intervention applied.

Detailed Description

The orogastric will then be informed about the investigations of the premature babies to be removed. It will be held in a place where video recordings will be taken from the parent during the orogastric catheter insertion process. After informed consent is obtained, the group to be included will be determined by predetermined stratified randomization.

Standard treatment will be applied to all preterms. Standard approach; Wrapping data during painful and stressful interventions is an effective method to calm the data and shorten the spread (Gardner and Goldson, 2011). As shown by Erkut and Yıldız with 74 newborns, births wrapped during heel bleeding had lower pain scores and higher oxygen saturation temperatures than the control groups (Erkut and Yıldız, 2017). The wrapping application will be wrapped in the flexion and abduction positions of the pre-terms, as a subscription for all members, in a way that does not cause movement restriction.

Babies are cared for every morning between 08.00 and 08.30. During care, orogastric catheters, tubes, and probes are renewed. Hand, face, and body care and oral care are provided and diapers are changed. Orgastric catheters of the babies included in the study will be removed during care hours. Maintenance takes approximately 15 minutes. Wrapping will be applied as standard treatment to all babies included in the study. After the care was done, it was wrapped early and allowed to rest. They are fed at 09.00. Preterms to be included in the study in each group; 30-45 without insertion of orogastric tube. They will be wrapped up in their beds and will be in a rest period where they will not be disturbed until minutes before. Oragastric catheters will be removed before feeding at 9:00. Video recording will be made starting before the procedure of connecting to the oragastric catheter (2 minutes).

Conditions

Prematurity; Pain Acute; Comfort; Orogastric Tube Insertion

Study Design

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

Study Groups

Breast milk

Breast Milk Intervention: Wrapping was applied to the baby as a standard approach. 2 minutes before the insertion of the oragastric catheter, 2 ml of breast milk was given to the babys mouth with a syringe. After the baby was given breast milk, video recording started. The steps for inserting an orogastric catheter were followed, and the baby was monitored in an incubator during the application, with pulse and saturation monitored.

Group Type: EXPERIMENTAL

breast milk

Intervention Type: OTHER

give breast milk before the OG catheter insertion

Dextrose

Dextrose Intervention: The baby will receive wrapping as standard treatment. The orogastric catheter is visible to the brim with 2 ml of 20% dextrose syringe 2 minutes before the insertion chamber (Bueno et al., 2013). After the baby is given dextrose, the video recording will start. The steps of the orogastric tube insertion procedure will be followed. The baby will be in an incubator during the application, with pulse and saturation monitored.

Group Type: EXPERIMENTAL

dextrose

Intervention Type: OTHER

give %20 dextrose before the OG catheter insertion

Control group

The control group: Baby will be wrapped as standard treatment. Video recording will start 2 minutes before the baby is inserted into the orogastric catheter. The steps of the orogastric tube insertion procedure will be followed. The baby will be in an incubator during the application, with pulse and saturation monitored. No additional intervention will be applied to the baby.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

breast milk

give breast milk before the OG catheter insertion

Intervention Type: OTHER

dextrose

give %20 dextrose before the OG catheter insertion

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Birth week 32-34,

• Postnatal week has reached 32-34 weeks,
• Birth weight over 1500 grams,
• whose general condition is stable,
• Planned to insert an orogastric tube,
• Developed sucking and swallowing reflexes, being able to hold a pacifier,
• Having breast milk,
• Preterms whose parents agreed to participate in the study were included in the study.

Exclusion Criteria

• In need of oxygen support,

• Receiving analgesic and/or sedation treatment,
• In the preoperative and/or postoperative period,
• Those with congenital anomalies of the mouth and palate,
• Those with metabolic (e.g. NEC) and genetic (e.g. osteogenesis imperfecta) diseases,
• Painful intervention was performed at least 30 minutes before the procedure, Preterm babies will be excluded from the research.

• Minimum Eligible Age: 32 Weeks
• Maximum Eligible Age: 34 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dokuz Eylul University

OTHER

Sponsor Role: lead

Responsible Party

Gülçin Özalp Gerçeker

Assoc. Prof., RN

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sevgi Güven

Role: STUDY_DIRECTOR

Dokuz Eylul University

Locations

Dokuz Eylul University

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

buchOG

Identifier Type: -

Identifier Source: org_study_id