The Effect of Feeding Positions During Tube Feeding on Stress, Pain Level and Feeding Tolerance of Preterm Infants
NCT ID: NCT04156529
Last Updated: 2019-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
34 participants
INTERVENTIONAL
2019-05-06
2019-08-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
SINGLE
Study Groups
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ESU position
Firstly, the semi-elevated supine position was given to participants during tube feeding
ESU position
Semi-elevated supine (ESU) position was given during tube feeding
ESRL position
Semi-elevated right lateral (ESRL) position was given during tube feeding
ESRL position
Firstly, the semi-elevated right lateral position was given to participants during tube feeding
ESU position
Semi-elevated supine (ESU) position was given during tube feeding
ESRL position
Semi-elevated right lateral (ESRL) position was given during tube feeding
Interventions
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ESU position
Semi-elevated supine (ESU) position was given during tube feeding
ESRL position
Semi-elevated right lateral (ESRL) position was given during tube feeding
Eligibility Criteria
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Inclusion Criteria
* stable vital signs,
* no oral feeding skills,
* feeding by orogastric tube,
* had parental consent
Exclusion Criteria
* congenital anomalies,
* necrotizing enterocolitis history,
* neurological and cardiological problems,
* receiving analgesic, sedative, or muscle relaxant medication that may affect pain and stress
30 Weeks
34 Weeks
ALL
No
Sponsors
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Sibel Serap Ceylan
OTHER
Responsible Party
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Sibel Serap Ceylan
Principal Investigator
Principal Investigators
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Sibel Serap Ceylan
Role: STUDY_DIRECTOR
Pamukkale Univesity
Locations
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Sibel Serap Ceylan
Denizli, , Turkey (Türkiye)
Countries
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References
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Khatony A, Abdi A, Karimi B, Aghaei A, Brojeni HS. The effects of position on gastric residual volume of premature infants in NICU. Ital J Pediatr. 2019 Jan 8;45(1):6. doi: 10.1186/s13052-018-0591-9.
Dsilna A, Christensson K, Gustafsson AS, Lagercrantz H, Alfredsson L. Behavioral stress is affected by the mode of tube feeding in very low birth weight infants. Clin J Pain. 2008 Jun;24(5):447-55. doi: 10.1097/AJP.0b013e3181633fd6.
Other Identifiers
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PamukkaleUniversity
Identifier Type: -
Identifier Source: org_study_id
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