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Developing and Validating Digital Affective Patient Experience/Outcome Measure

Developing and Validating Digital Affective Patient Experience/Outcome Measure

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03337321
Acronym
ETVa
Enrollment
1000
Registered
2017-11-09
Start date
2018-01-13
Completion date
2020-12-31
Last updated
2020-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Affective; Reaction, Pregnancy Related, Validation Studies

Keywords

pregnancy, emotions, patient experience, maternal care

Brief 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. 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.

Interventions

None listed

Sponsors

Aalto University
CollaboratorOTHER
Helsinki University Central Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

Inclusion criteria

* ongoing pregnancy * attending maternal care in the Hospital District of Helsinki and Uusimaa * fluent in Finnish * access to mobile communication device

Exclusion criteria

none

Design outcomes

Primary

MeasureTime frameDescription
three-dimensional affective ratings9 monthsaffective rating of 195 emotion words in relation to pleasure, arousal, dominance (Lang 1980)

Secondary

MeasureTime frameDescription
anxiety9 monthsGeneralized 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.

Other

MeasureTime frameDescription
health related quality of life9 monthsPROMIS-10 (Cella et al 2007)
emotional stress reaction9 monthsEmotional Stress Reaction Questionnaire (ESRQ) (Larsson&Wilde-Larsson 2010)
S5 personality traits (30 facets of the Five-Factor Model)9 monthsShort Five S5, a 60-item questionnaire (Konstabel et al 2012), is used to measure personality traits, more specifically, the 30 facets of the Five-Factor Model, using comprehensive single items (CSI).
patient experience in maternal care9 monthsPregnancy- and maternity-care patients' experiences questionnaire (PreMaPeq) (Sjetne et al 2015)
subjective well-being9 monthsSubjective Well-Being Questionnaire (SWB) (Lee et al 2013)
emotion regulation9 monthsState and Trait meta-mood questionnaire (adapted from: Mayer & Stevens 1994; Salovey et al 1995)

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026