ClinicalTrials.Veeva

Menu

The Effect of Feeding Positions During Tube Feeding on Stress, Pain Level and Feeding Tolerance of Preterm Infants

S

Sibel Serap Ceylan

Status

Completed

Conditions

Pain
Enteral Feeding Intolerance
Stress

Treatments

Behavioral: ESRL position
Behavioral: ESU position

Study type

Interventional

Funder types

Other

Identifiers

NCT04156529
PamukkaleUniversity

Details and patient eligibility

About

Premature infants have a need for an orogastric or nasogastric feeding tube because of the immaturity of coordination between suck-swallow and breathing. Tube feeding could cause feeding intolerance and stress. One of the recommendations to prevent feeding intolerance is giving suitable position during tube feeding. Also, feeding intolerance is related to stress. The aim of this study was to investigate the effect of semi-elevated supine (ESU) and semi-elevated right lateral (ESRL) positions on the stress, pain levels and feeding tolerance of premature infants during the tube feeding (TF). This was a clinical trial with a crossover design in which subjects randomly received a sequence of either ESU position or ESRL position, during the TF.

Full description

Purpose: The aim of this study was to investigate the effect of semi-elevated supine (ESU) and semi-elevated right lateral (ESRL) positions on the stress, pain levels and feeding tolerance of premature infants during the tube feeding (TF).

Method: This was a clinical trial with a crossover design in which subjects randomly received a sequence of either ESU position or ESRL position, during the TF. The sample size calculation was based on the crossover design. It assumed criteria that included the expectation of minimal differences in the average pain and stress score, 1.0; a difference of 2.0 in the standard deviation between ESU and ESRL positions; power, 0.80 and p < .05. The sample size was calculated to be 34 participants. The inclusion criteria for participants were 30-34 weeks gestational age, stable vital signs, no oral feeding skills, feeding by orogastric tube, and had parental consent. Exclusion criteria were respiratory distress, congenital anomalies, necrotizing enterocolitis history, neurological and cardiological problems, receiving analgesic, sedative, or muscle relaxant medication that may affect pain and stress. The position to be given to the participants during TF first was determined by randomization. The sequence of feeding position was randomized by computer. Sixteen of the infants started TF with ESU position, whereas the other 18 started with ESRL position.

The study data were collected with "Descriptive Properties Form of Premature Newborn", Premature Newborn Follow-up Form", "Newborn Stress Scale", "ALPS-Neo Newborn Pain and Stress Assessment Scale".

For each participant, two feeding positions were applied at consecutive feeding time. Feeding tolerance was assessed by abdominal circumference measurements and checking gastric residuals. The abdominal circumference of the participants was measured with a tape measure before and after TF. Vital signs and oxygen saturation levels were measured before, during and after TF. The stress and pain levels of the participants were evaluated independently by the researchers before, during and after TF. Significance level p <0.05 was used for all statistical analyses. Ethics committee approval, written permission from institutions and families were obtained for conducting the study.

Enrollment

34 patients

Sex

All

Ages

30 to 34 weeks old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 30-34 weeks gestational age,
  • stable vital signs,
  • no oral feeding skills,
  • feeding by orogastric tube,
  • had parental consent

Exclusion criteria

  • respiratory distress,
  • congenital anomalies,
  • necrotizing enterocolitis history,
  • neurological and cardiological problems,
  • receiving analgesic, sedative, or muscle relaxant medication that may affect pain and stress

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

34 participants in 2 patient groups

ESU position
Experimental group
Description:
Firstly, the semi-elevated supine position was given to participants during tube feeding
Treatment:
Behavioral: ESU position
Behavioral: ESRL position
ESRL position
Experimental group
Description:
Firstly, the semi-elevated right lateral position was given to participants during tube feeding
Treatment:
Behavioral: ESU position
Behavioral: ESRL position

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems