Affective; ReactionETVaNCT03337321
Developing and Validating Digital Affective Patient Experience/Outcome Measure
An observational study of Affective; Reaction and Pregnancy Related, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
The aim of the research project is to develop and validate a new digital measure of affective patient experience in maternal care. In this validating study extensive collection of affective ratings of 195 emotion words is collected. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Affective; Reaction, Pregnancy Related, Validation Studies
- How many people
- 1,000 participants
- Where
- 1 siteFinland
- Study dates
- 13 Jan 2018to Dec 2020
- Phase
- Observational
- 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
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pregnant women attending maternal care in the Hospital District of Helsinki and Uusimaa
Who may be able to join
- ongoing pregnancy
- attending maternal care in the Hospital District of Helsinki and Uusimaa
- fluent in Finnish
- access to mobile communication device
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Finland1 site
The Hospital District of Helsinki and Uusimaa
Helsinki, Uusimaa, 00029
About this study
The aim of the research project is to develop and validate a new digital measure of affective patient experience in maternal care. In this validating study extensive collection of affective ratings of 195 emotion words is collected. Pregnant women at different gestational stages are asked to provide affective ratings of 195 emotion words in relation to the dimensions: pleasure, arousal, dominance. Based on these ratings population averages and properties of emotion words will be calculated. The measure will be developed in respect to the analysis of affective rating and supplementing data.
Read the detailed description
As there is an increasing demand for and interest in measures that take patient's emotions into account, this research project aims to develop and validate a new digital measure of affective patient-reported experience/outcome in maternal care.
In this validating study extensive collection of affective ratings of 195 emotion words will be collected. Pregnant women (N=1000) at different gestational stages are asked to provide affective ratings of 195 emotion words in relation to the dimensions: pleasure, arousal, dominance. This is done by using a visual Likert scale (Self-Assessment Manikin). The pregnant women participating in the research are also asked to answer to various questionnaires to identify patterns of personality, behavior and the state of health and well-being. Based on the affective ratings population averages and properties of emotion words will be calculated. The measure will be developed in respect to the analysis of affective ratings and supplementing data.
The research provides insights on how affective ratings could be connected to clinical indicators and patient experience.
- Conditions
- Affective; Reaction, Pregnancy Related, Validation Studies
- Keywords
- pregnancy, emotions, patient experience, maternal care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ETvalid | Pregnant women attending maternal care services and having access to computational device |
What is being measured
The primary outcome is the main question the study is designed to answer.
three-dimensional affective ratings
affective rating of 195 emotion words in relation to pleasure, arousal, dominance (Lang 1980)
Measured: 9 months
Secondary outcomes (1)
anxiety
Generalized Anxiety Disorder Scale (GAD-7) (Spitzer et al. 2006). Scale is from 0 to 21. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start13 Jan 2018
- Primary completion28 Feb 2020
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Affective; ReactionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aalto University
- Responsible party
- Principal investigator, Maritta Poyhonen-Alho, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337321
- Sponsor's protocol ID
- 2329/2016
- Acronym
- ETVa
- Status last verified
- Apr 2020
- First submitted
- 17 Oct 2017
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lang, P. J. (1980). Behavioral treatment and bio-behavioral assessment: computer applications. In J. B. Sidowski, J. H. Johnson, & T. A. Williams (Eds.), Technology in mental health care delivery systems (pp. 119-l37). Norwood, NJ: Ablex.
Konstabel, K., Lönnqvist, J.-E., Walkowitz, G., Konstabel, K. and Verkasalo, M. (2012), The 'Short Five' (S5): Measuring personality traits using comprehensive single items. European Journal of Personality, 26(1), 13-29. doi:10.1002/per.813
Mayer, J., & Stevens, A. (1994). An emerging understanding of the reflective (meta-) experience of mood. Journal of Research in Personality, 28, 351-373.
Salovey, P., Mayer, J. D., Goldman, S. L., Turvey, C., and Palfai, T. P. (1995). Emotional attention, clarity, and repair: Exploring emotional intelligence using the Trait Meta-Mood Scale. In J. W. Pennebaker (Ed.), Emotion, Disclosure and Health (pp.125-151). Washington, DC: American Psychological Association.
Cella D, Yount S, Rothrock N, Gershon R, Cook K, Reeve B, Ader D, Fries JF, Bruce B, Rose M; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years. Med Care. 2007 May;45(5 Suppl 1):S3-S11. doi: 10.1097/01.mlr.0000258615.42478.55.
PubMed 17443116Larsson G, Wilde-Larsson B. Quality of care and patient satisfaction: a new theoretical and methodological approach. Int J Health Care Qual Assur. 2010;23(2):228-47. doi: 10.1108/09526861011017120.
PubMed 21388102Lee H, Vlaev I, King D, Mayer E, Darzi A, Dolan P. Subjective well-being and the measurement of quality in healthcare. Soc Sci Med. 2013 Dec;99:27-34. doi: 10.1016/j.socscimed.2013.09.027. Epub 2013 Oct 8.
PubMed 24355467Sjetne IS, Iversen HH, Kjollesdal JG. A questionnaire to measure women's experiences with pregnancy, birth and postnatal care: instrument development and assessment following a national survey in Norway. BMC Pregnancy Childbirth. 2015 Aug 21;15:182. doi: 10.1186/s12884-015-0611-3.
PubMed 26294064Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Validating Digital Affective Patient Experience/Outcome Measure
- ClinicalTrials.gov ID
- NCT03337321
- Acronym / sponsor ID
- ETVa / 2329/2016
- Conditions
- Affective; Reaction, Pregnancy Related, Validation Studies
- Keywords
- pregnancy, emotions, patient experience, maternal care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Aalto University
- Study start
- 13 Jan 2018 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- Dec 2020 (estimated)
- First posted
- 9 Nov 2017 (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.
The aim of the research project is to develop and validate a new digital measure of affective patient experience in maternal care. In this validating study extensive collection of affective ratings of 195 emotion words is collected. Pregnant women at different gestational stages are asked to provide affective ratings of 195 emotion words in relation to the dimensions: pleasure, arousal, dominance. Based on these ratings population averages and properties of emotion words will be calculated. The measure will be developed in respect to the analysis of affective rating and supplementing data.
Detailed description
As there is an increasing demand for and interest in measures that take patient's emotions into account, this research project aims to develop and validate a new digital measure of affective patient-reported experience/outcome in maternal care.
In this validating study extensive collection of affective ratings of 195 emotion words will be collected. Pregnant women (N=1000) at different gestational stages are asked to provide affective ratings of 195 emotion words in relation to the dimensions: pleasure, arousal, dominance. This is done by using a visual Likert scale (Self-Assessment Manikin). The pregnant women participating in the research are also asked to answer to various questionnaires to identify patterns of personality, behavior and the state of health and well-being. Based on the affective ratings population averages and properties of emotion words will be calculated. The measure will be developed in respect to the analysis of affective ratings and supplementing data.
The research provides insights on how affective ratings could be connected to clinical indicators and patient experience.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ETvalid | – | –Pregnant women attending maternal care services and having access to computational device |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women attending maternal care in the Hospital District of Helsinki and Uusimaa
Key inclusion criteria (4 listed)
- ongoing pregnancy
- attending maternal care in the Hospital District of Helsinki and Uusimaa
- fluent in Finnish
- access to mobile communication device
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
three-dimensional affective ratings
Time frame: 9 months
affective rating of 195 emotion words in relation to pleasure, arousal, dominance (Lang 1980)
1 secondary outcome
anxiety
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
- BackgroundLang, P. J. (1980). Behavioral treatment and bio-behavioral assessment: computer applications. In J. B. Sidowski, J. H. Johnson, & T. A. Williams (Eds.), Technology in mental health care delivery systems (pp. 119-l37). Norwood, NJ: Ablex.
- BackgroundKonstabel, K., Lönnqvist, J.-E., Walkowitz, G., Konstabel, K. and Verkasalo, M. (2012), The 'Short Five' (S5): Measuring personality traits using comprehensive single items. European Journal of Personality, 26(1), 13-29. doi:10.1002/per.813
- BackgroundMayer, J., & Stevens, A. (1994). An emerging understanding of the reflective (meta-) experience of mood. Journal of Research in Personality, 28, 351-373.
- BackgroundSalovey, P., Mayer, J. D., Goldman, S. L., Turvey, C., and Palfai, T. P. (1995). Emotional attention, clarity, and repair: Exploring emotional intelligence using the Trait Meta-Mood Scale. In J. W. Pennebaker (Ed.), Emotion, Disclosure and Health (pp.125-151). Washington, DC: American Psychological Association.
- Background: PubMed 17443116Cella D, Yount S, Rothrock N, Gershon R, Cook K, Reeve B, Ader D, Fries JF, Bruce B, Rose M; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years. Med Care. 2007 May;45(5 Suppl 1):S3-S11. doi: 10.1097/01.mlr.0000258615.42478.55.
- Background: PubMed 21388102Larsson G, Wilde-Larsson B. Quality of care and patient satisfaction: a new theoretical and methodological approach. Int J Health Care Qual Assur. 2010;23(2):228-47. doi: 10.1108/09526861011017120.
- Background: PubMed 24355467Lee H, Vlaev I, King D, Mayer E, Darzi A, Dolan P. Subjective well-being and the measurement of quality in healthcare. Soc Sci Med. 2013 Dec;99:27-34. doi: 10.1016/j.socscimed.2013.09.027. Epub 2013 Oct 8.
- Background: PubMed 26294064Sjetne IS, Iversen HH, Kjollesdal JG. A questionnaire to measure women's experiences with pregnancy, birth and postnatal care: instrument development and assessment following a national survey in Norway. BMC Pregnancy Childbirth. 2015 Aug 21;15:182. doi: 10.1186/s12884-015-0611-3.
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- The Institute of Healthcare Engineering, Management and Architecture (the HEMA Institute) at Aalto University School of Science, FinlandLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Affective; Reaction and Pregnancy Related, run by Helsinki University Central Hospital at 1 site in Finland.
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 4 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 8 Apr 2020. 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 Finland. 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?
Results are not available in the source record.
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?
three-dimensional affective ratings (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03337321, which also lists 9 linked publications.
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 8 Apr 2020.