Clinical trial NCT03337321: Developing and Validating Digital Affective Patient Experience/Outcome Measure
Official title: Developing and Validating Digital Affective Patient Experience/Outcome Measure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Affective; Reaction
Pregnancy Related
Validation Studies
Keywords: pregnancy
emotions
patient experience
maternal care
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Aalto University
First posted: 2017-11-09
Enrollment: 1000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women attending maternal care in the Hospital District of Helsinki and Uusimaa

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.

Eligibility criteria: 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

Primary outcomes:
measure: three-dimensional affective ratings
timeFrame: 9 months
Secondary outcomes:
measure: anxiety
timeFrame: 9 months
Other outcomes:
measure: S5 personality traits (30 facets of the Five-Factor Model)
timeFrame: 9 months
measure: emotion regulation
timeFrame: 9 months
measure: health related quality of life
timeFrame: 9 months
measure: emotional stress reaction
timeFrame: 9 months
measure: subjective well-being
timeFrame: 9 months
measure: patient experience in maternal care
timeFrame: 9 months
Locations:
city: Helsinki
country: Finland
facility: The Hospital District of Helsinki and Uusimaa
state: Uusimaa
Study officials:
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