Parents Clinical Trial
Official title:
Pain Responses in Preterm Infants and Parental Stress Over Repeated Painful Procedures: a Randomized Pilot Trial.
NCT number | NCT05656677 |
Other study ID # | 079/13 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 1, 2019 |
Est. completion date | November 1, 2022 |
Verified date | December 2022 |
Source | University Hospital Inselspital, Berne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This pilot study was conceptualised to determine the feasibility of involving parents via facilitated tucking or observing during painful procedures and to measure change in parental stress and infant pain. An additional purpose of this pilot study was to determine the size of the cohort of preterm infants needed for a larger trial, the time, and resources required for recruitment and data collection.
Status | Completed |
Enrollment | 20 |
Est. completion date | November 1, 2022 |
Est. primary completion date | November 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Premature infants born at the NICU concerned - Born between 24 0/7- 32 0/7 weeks of gestation, birthweight (bw) <1250g - Infant in need of s.c. erythropoietin - Parents fluently speaking and writing in German - Written informed consent by parents Exclusion Criteria: - Premature infant with an umbilical artery pH measurement <7.00 or asphyxia - Premature infant with life threatening malformations of the central nervous system - Premature infant with intracranial haemorrhage (even if not present at the start of the study) - Premature infant with any surgical intervention - Parents with substance abuse (i.e., methadone, heroin, etc.), as mentioned in the electronic patient documentation (EPD) |
Country | Name | City | State |
---|---|---|---|
Switzerland | Inselspital | Bern |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The main objective of this pilot study was to determine the feasibility of a larger, appropriately powered study | Feasibility assessment included recruitment rate (dependent on resources and in-/exclusion criteria) | 1 year | |
Primary | Percentage of questionnaire completion | Check percentage of questionnaires completed and withdrawals
Interview parents about the feasibility of participating three times |
1 year | |
Primary | The pain and stress measurement over three time points were reviewed for feasibility | -The research team was also interviewed about acceptance, applicability and feasibility of the validated BPSN, the SCA over three time points | 1 year | |
Primary | The active parental involvement over three time points were reviewed for feasibility | In semi-structured interviews, parents were asked about performing facilitated tucking or standing by as observers, acceptance, applicability and feasibility of the CSSQ and measurement over three time-points
-The research team was also interviewed about active parental involvement |
1 year | |
Secondary | The secondary interest of the study was to test for significant differences in parental stress between the two intervention and control group at three measurement points as well as infant pain. | To determine infant pain, two research team nurses observed the infant by using the Bernese Pain Scale for Neonates (BPSN) in real time before (2-3 minutes), during and (2-3 and 10 minutes) after the s.c. injection. The two nurses independently assessed the physiological and behavioural pain items [(18)]. The BPSN is a multidimensional tool in German and has shown satisfactory psychometric properties among preterm and term infants (validity: r = 0.75; reliability: a=0.8) [(18)].
Skin Conductance Algesimeter (SCA) was installed before the s.c. injection until the last BPSN measurement. An electrocardiogram electrode (ECG) was placed on the sole of the foot to the left and right of the ankle of the preterm infant. An initial baseline was obtained. Subsequently, SCA pain measurement was continuous. |
1 year |
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