Developing and Validating Digital Affective Patient Experience/Outcome Measure

• Conditions: Affective; Reaction; Pregnancy Related; Validation Studies

• Registration Number: NCT03337321
• Lead Sponsor: Helsinki University Central Hospital

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.

Study Timeline

• Study First Submitted: 2017-10-17
• Study First Submitted QC: 2017-11-06
• Study First Posted: 2017-11-09
• Study Start: 2018-01-13
• Primary Completion: 2020-02-28
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-07
• Last Update Posted: 2020-04-08
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
three-dimensional affective ratings	9 months	affective rating of 195 emotion words in relation to pleasure, arousal, dominance (Lang 1980)

Secondary Outcome Measures

Name	Time	Method
anxiety	9 months	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.

Trial Locations

Locations (1)

The Hospital District of Helsinki and Uusimaa; 🇫🇮 Helsinki, Uusimaa, Finland