Developing and Validating Digital Affective Patient Experience/Outcome Measure (ETVa)

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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• Finland
  • Uusimaa
    • Helsinki, Uusimaa, Finland, 00029
      • The Hospital District of Helsinki and Uusimaa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Pregnant women attending maternal care in the Hospital District of Helsinki and Uusimaa

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
ETvalid; Pregnant women attending maternal care services and having access to computational device

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	9 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
S5 personality traits (30 facets of the Five-Factor Model)	Short 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).	9 months
emotion regulation	State and Trait meta-mood questionnaire (adapted from: Mayer & Stevens 1994; Salovey et al 1995)	9 months
health related quality of life	PROMIS-10 (Cella et al 2007)	9 months
emotional stress reaction	Emotional Stress Reaction Questionnaire (ESRQ) (Larsson&Wilde-Larsson 2010)	9 months
subjective well-being	Subjective Well-Being Questionnaire (SWB) (Lee et al 2013)	9 months
patient experience in maternal care	Pregnancy- and maternity-care patients' experiences questionnaire (PreMaPeq) (Sjetne et al 2015)	9 months

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Collaborators: Aalto University

Publications and helpful links

General Publications

• Spitzer 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.
• 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.
• 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.
• Larsson 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.
• Lee 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.
• Sjetne 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.

Helpful Links

• The Institute of Healthcare Engineering, Management and Architecture (the HEMA Institute) at Aalto University School of Science, Finland

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2018
• Primary Completion (Actual): February 28, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: October 17, 2017
• First Submitted That Met QC Criteria: November 6, 2017
• First Posted (Actual): November 9, 2017

Study Record Updates

• Last Update Posted (Actual): April 8, 2020
• Last Update Submitted That Met QC Criteria: April 7, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: pregnancy; patient experience; emotions; maternal care
• Other Study ID Numbers: 2329/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No