Procedural PainNCT05656677
Parental Involvement in Pain Reducing Measures
A study testing Passive parental involvement and Active parental involvement in people with Procedural Pain and Preterm Infants, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Procedural Pain, Preterm Infants, Parents
- What is being tested?
- Passive parental involvement and Active parental involvement
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2019to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Responses in Preterm Infants and Parental Stress Over Repeated Painful Procedures: a Randomized Pilot Trial.
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.
Read the 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.
- Conditions
- Procedural Pain, Preterm Infants, Parents
- Being tested
- Passive parental involvement, Active parental involvement
- Keywords
- pain, stress, preterm infants, parents
- Medical subject headings
- Pain, Procedural, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive parental involvementBehavioural
One parent watching a procedural painful intervention, two nurses executing facilitated tucking
Active parental involvementRadiation
One parent watching a procedural painful intervention and at the same time executing facilitated tucking
| Study group | Role | What they receive |
|---|---|---|
| Two nurses executing facilitated tucking (FT) | No intervention | Usual care |
| One parent watching passively | Active comparator | One parent watching passively the 2 nurses executing FT Receives: Behavioral: Passive parental involvement |
| One parent actively involved | Active comparator | One parent actively executing FT Receives: Radiation: Active parental involvement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year
Percentage of questionnaire completion
- Check percentage of questionnaires completed and withdrawals
- Interview parents about the feasibility of participating three times
Measured: 1 year
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
Measured: 1 year
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
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start1 Oct 2019
- Primary completion1 Nov 2020
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra Zwakhalen, Prof. Dr., Study chair, Fac. Health, Medicine and Life Sciences, Health Services Research CAPHRI - University of Maastricht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656677
- Sponsor's protocol ID
- 079/13
- Status last verified
- Dec 2022
- First submitted
- 30 Nov 2022
- Last updated
- 19 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collection of pain assessment
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Responses in Preterm Infants and Parental Stress Over Repeated Painful Procedures: a Randomized Pilot Trial.
- ClinicalTrials.gov ID
- NCT05656677
- Acronym / sponsor ID
- 079/13
- Conditions
- Procedural Pain, Preterm Infants, Parents
- Keywords
- pain, stress, preterm infants, parents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Two nurses executing facilitated tucking (FT) | No intervention | –Usual care |
| One parent watching passively | Active comparator | Behavioral: Passive parental involvementOne parent watching passively the 2 nurses executing FT |
| One parent actively involved | Active comparator | Radiation: Active parental involvementOne parent actively executing FT |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Passive parental involvementOne parent watching a procedural painful intervention, two nurses executing facilitated tucking | Behavioural | One parent watching passively |
| Active parental involvementOne parent watching a procedural painful intervention and at the same time executing facilitated tucking | Radiation | One parent actively involved |
Primary outcome
The main objective of this pilot study was to determine the feasibility of a larger, appropriately powered study
Time frame: 1 year
Feasibility assessment included recruitment rate (dependent on resources and in-/exclusion criteria)
Percentage of questionnaire completion
Time frame: 1 year
* 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
Time frame: 1 year
-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
Time frame: 1 year
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 secondary outcome
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.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
- Individual participant dataSharing planned: Yes. Data collection of pain assessment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Zwakhalen, Prof. Dr. study chair
Fac. Health, Medicine and Life Sciences, Health Services Research CAPHRI - University of Maastricht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive parental involvement and Active parental involvement in people with Procedural Pain and Preterm Infants, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main objective of this pilot study was to determine the feasibility of a larger, appropriately powered study (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2022.