NCT03337321

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 9, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 13, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 8, 2020

Status Verified

April 1, 2020

Enrollment Period

2.1 years

First QC Date

October 17, 2017

Last Update Submit

April 7, 2020

Conditions

Affective; ReactionPregnancy RelatedValidation Studies

Keywords

pregnancyemotionspatient experiencematernal care

Outcome Measures

Primary Outcomes (1)

  • three-dimensional affective ratings

    affective rating of 195 emotion words in relation to pleasure, arousal, dominance (Lang 1980)

    9 months

Secondary Outcomes (1)

  • anxiety

    9 months

Other Outcomes (6)

  • S5 personality traits (30 facets of the Five-Factor Model)

    9 months

  • emotion regulation

    9 months

  • health related quality of life

    9 months

  • +3 more other outcomes

Study Arms (1)

ETvalid

Pregnant women attending maternal care services and having access to computational device

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital District of Helsinki and Uusimaa

Helsinki, Uusimaa, 00029, Finland

Location

Related Publications (9)

  • 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.

    BACKGROUND

  • 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

    BACKGROUND

  • Mayer, J., & Stevens, A. (1994). An emerging understanding of the reflective (meta-) experience of mood. Journal of Research in Personality, 28, 351-373.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 17443116BACKGROUND

  • 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.

    PMID: 21388102BACKGROUND

  • 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.

    PMID: 24355467BACKGROUND

  • 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.

    PMID: 26294064BACKGROUND

  • 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.

    PMID: 16717171BACKGROUND

Related Links

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 17, 2017

First Posted

November 9, 2017

Study Start

January 13, 2018

Primary Completion

February 28, 2020

Study Completion

December 1, 2020

Last Updated

April 8, 2020

Record last verified: 2020-04

Locations

FI(1)