Clinical trial NCT06222047: Pain and Comfort Level During Orogastric Catheter Insertion in Preterms
Official title: The Effect of Breast Milk and Dextrose on the Orogastric Tube Insertion-related Pain and Comfort Levels of Preterm Babies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prematurity
Pain Acute
Comfort
Orogastric Tube Insertion
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 60
Sex: ALL
Minimum age (years): 32
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Breast Milk Dextrose Control
Primary purpose: SUPPORTIVE_CARE

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).

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.

Primary outcomes:
measure: OG catheter-related pain
timeFrame: 2 minutes before the OG tube insertion, during the OG tube insertion, 2 minutes after the OG tube insertion
measure: OG catheter-related comfort
timeFrame: 2 minutes before the OG tube insertion, during the OG tube insertion, 2 minutes after the OG tube insertion
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylul University
Study officials:
affiliation: Dokuz Eylul University
name: Sevgi Güven
role: STUDY_DIRECTOR
References: