search
Back to results

Parental Involvement in Pain Reducing Measures

Primary Purpose

Procedural Pain, Preterm Infants, Parents

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Passive parental involvement
Active parental involvement
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Procedural Pain focused on measuring pain, stress, preterm infants, parents

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Inselspital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Two nurses executing facilitated tucking (FT)

One parent watching passively

One parent actively involved

Arm Description

Usual care

One parent watching passively the 2 nurses executing FT

One parent actively executing FT

Outcomes

Primary Outcome Measures

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)
Percentage of questionnaire completion
Check percentage of questionnaires completed and withdrawals Interview parents about the feasibility of participating three times
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
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

Secondary Outcome Measures

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: α=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.

Full Information

First Posted
November 30, 2022
Last Updated
December 12, 2022
Sponsor
Insel Gruppe AG, University Hospital Bern
search

1. Study Identification

Unique Protocol Identification Number
NCT05656677
Brief Title
Parental Involvement in Pain Reducing Measures
Official Title
Pain Responses in Preterm Infants and Parental Stress Over Repeated Painful Procedures: a Randomized Pilot Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
November 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Objectives In this pilot study, the aims were to determine the feasibility of whether pain behaviour in extremely and very preterm infants and perceived parental stress change when parents are involved in pain reducing measures, either actively, performing facilitated tucking or passively, observing the intervention, in comparison to the involvement of nurses only. In addition, the infant's pain reactivity and parental stress over three time points of measurement was of interest. Methods Extremely and very preterm infants in need of subcutaneous erythropoietin were randomly assigned to the two intervention groups. The intervention encompassed that one parent of each infant was involved during the painful procedure: Either parents executed facilitated tucking themselves or stood by, observing the procedure. Usual care involved that nurse executed facilitated tucking. All infants received 0.5ml of 30% oral glucose solution via cotton swab before the painful procedure. Infant pain was observed with the Bernese Pain Scale for Neonates (BPSN) and measured with the skin conductance algesimeter (SCA) before, during, and after the procedure. Parents' stress levels were measured before and after the painful procedure on the infant, using the Current Strain Short Questionnaire (CSSQ). Feasibility of a subsequent trial was determined by assessing recruitment, measurement and active parental involvement. Quantitative data collection methods (i.e., questionnaires, algesimeter) were employed to determine the number of participants for a larger trial and measurement adequacy. Qualitative data (interviews) was employed to determine parents' perspectives of their involvement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Procedural Pain, Preterm Infants, Parents
Keywords
pain, stress, preterm infants, parents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A three-arm pilot study using mixed methods of data collection (questionnaires, SCA, interviews) was designed to test the feasibility of the intervention encompassing parents' active and passive involvement in procedural pain management of extremely and preterm infants hospitalised at a neonatal intensive care unit (NICU).
Masking
ParticipantCare ProviderInvestigator
Masking Description
The six NICU nurses involved were blinded to the purpose of the study, whereas the clinical nurse specialist (CNS) was not. Always three members of this research team conducted the pain assessment during the facilitated tucking or the observing by the parents. The other three members of the research team focused on the nurses' group. The CNS or the neonatologist provided information about the study to the parents, without stating its specific aim, instead referring in principle to the increased involvement of parents in pain management.
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Two nurses executing facilitated tucking (FT)
Arm Type
No Intervention
Arm Description
Usual care
Arm Title
One parent watching passively
Arm Type
Active Comparator
Arm Description
One parent watching passively the 2 nurses executing FT
Arm Title
One parent actively involved
Arm Type
Active Comparator
Arm Description
One parent actively executing FT
Intervention Type
Behavioral
Intervention Name(s)
Passive parental involvement
Intervention Description
One parent watching a procedural painful intervention, two nurses executing facilitated tucking
Intervention Type
Radiation
Intervention Name(s)
Active parental involvement
Intervention Description
One parent watching a procedural painful intervention and at the same time executing facilitated tucking
Primary Outcome Measure Information:
Title
The main objective of this pilot study was to determine the feasibility of a larger, appropriately powered study
Description
Feasibility assessment included recruitment rate (dependent on resources and in-/exclusion criteria)
Time Frame
1 year
Title
Percentage of questionnaire completion
Description
Check percentage of questionnaires completed and withdrawals Interview parents about the feasibility of participating three times
Time Frame
1 year
Title
The pain and stress measurement over three time points were reviewed for feasibility
Description
-The research team was also interviewed about acceptance, applicability and feasibility of the validated BPSN, the SCA over three time points
Time Frame
1 year
Title
The active parental involvement over three time points were reviewed for feasibility
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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.
Description
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: α=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.
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Zwakhalen, Prof. Dr.
Organizational Affiliation
Fac. Health, Medicine and Life Sciences, Health Services Research CAPHRI - University of Maastricht
Official's Role
Study Chair
Facility Information:
Facility Name
Inselspital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data collection of pain assessment
IPD Sharing Time Frame
1year
IPD Sharing Access Criteria
Personal request

Learn more about this trial

Parental Involvement in Pain Reducing Measures

We'll reach out to this number within 24 hrs