Pregnancy Related Clinical Trial
— ETVaOfficial title:
Developing and Validating Digital Affective Patient Experience/Outcome Measure
Verified date | April 2020 |
Source | Helsinki University Central Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 1000 |
Est. completion date | December 2020 |
Est. primary completion date | February 28, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Finland | The Hospital District of Helsinki and Uusimaa | Helsinki | Uusimaa |
Lead Sponsor | Collaborator |
---|---|
Helsinki University Central Hospital | Aalto University |
Finland,
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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
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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. — View Citation
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. — View Citation
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.
Sjetne IS, Iversen HH, Kjøllesdal 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. — View Citation
Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Other | emotion regulation | State and Trait meta-mood questionnaire (adapted from: Mayer & Stevens 1994; Salovey et al 1995) | 9 months | |
Other | health related quality of life | PROMIS-10 (Cella et al 2007) | 9 months | |
Other | emotional stress reaction | Emotional Stress Reaction Questionnaire (ESRQ) (Larsson&Wilde-Larsson 2010) | 9 months | |
Other | subjective well-being | Subjective Well-Being Questionnaire (SWB) (Lee et al 2013) | 9 months | |
Other | patient experience in maternal care | Pregnancy- and maternity-care patients' experiences questionnaire (PreMaPeq) (Sjetne et al 2015) | 9 months | |
Primary | three-dimensional affective ratings | affective rating of 195 emotion words in relation to pleasure, arousal, dominance (Lang 1980) | 9 months | |
Secondary | 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 |
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