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The influence of stress reduction during pregnancy on infant outcome

The influence of stress reduction during pregnancy on infant outcome - Pregnancy and Mindfulness

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35275
Enrollment
140
Registered
2011-12-13
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aangeboren kwetsbaarheid gerelateerd aan het stresssysteem (HPA-as en autonoom zenuwstelsel) attention problemes Stressregulationproblems

Interventions

A stress reduction intervention is given to the experimental group, weekly between week 15 and 23 of gestation and each session lasts 150 minutes, We will examine the short-term and long-term effect
a booklet is provided containing relevant information. Six weeks after the training, i.e. at 29 weeks of gestation (T3), questionnaires, physiological measures (and biochemical assays), including a

Sponsors

Universiteit van Tilburg
Lead Sponsor

Eligibility

Age
2 Years to 99 Years

Inclusion criteria

Inclusion criteria: Pregnant woman: -18 to 40 year old -score higher then Pc 67 on standardised stress and anxiety questionnaires -no substance abuse problems -no severe psychiatric problems -no pregnancy-related medical problems (e.g. diabetes, hypertension) or obstetrical problems

Exclusion criteria

Exclusion criteria: Pregnant woman: -other medical or obstetrical complications during this pregnancy -18 to 45 year old -score lower then Pc 67 on standardised stress and anxiety questionnaires -substance abuse problems -severe psychiatric problems -pregnancy-related medical problems (e.g. diabetes, hypertension) or obstetrical problems

Design outcomes

Primary

MeasureTime frame
1.Birth outcome:. Gestational length at birth and birth weight and length are important outcome measures (T4). 2.Psychological measures of mother. The State Trait Anxiety Inventory (STAI) and Perceived Stress Scale (PSS) are used to select women at recruitment and, together with the Pregnancy Anxiety Questionnaire (PRAQ-short) and the Five Factor Mindfulness Questionnaire (FFMQ), will also be completed to measure the effect of the MBSR and examine their association with the physiological stress measures. The STAI consists of 20 items measuring state anxiety (transient emotional condition) and trait anxiety (dispositional anxiety). The PSS, contains 10 items measuring the perception of stress. The FFMQ , has 39 items measuring five facets of mindfulness skills. The PRAQ-short measures anxieties related to pregnancy and contains 10 items. 3.Physiological measures and biochemical assays of the woman, fetus and infant 3.1. HPA-axis and ANS activity. Basal and stress-related activity is measured before, during, and after the standard TSST, which combines a mental arithmetic task with a free speech task in front of a critical audience and which has been shown to induce reliable physiological stress responses. Salivary cortisol is measured four times from before to one hour after the stressor. ANS activity is recorded using the validated Vrije Universiteit Ambulatory Monitoring System (UV-AMS; http://www.psy.vu.nl/vu-ams/) throughout the laboratory session. This device measures heart rate, heart rate variability, skin temperature, skin conductance and respiration frequency. In addition, in order to assess acute responses to mindfulness exercises, HR(V) will be measured during 50% of the MBSR sessions, i.e. 2-weekly at T2. Finally, to assess the cortisol awakening response (CAR) and diurnal profile, on the day before the laboratory stress test (TSST), the mothers will provide 6 saliva samples: at awakening, 30, 45 and 60 minutes after awakening (to

Secondary

MeasureTime frame
Relevant covariates. Maternal age, parity, gravidity, education, socio-economic status (SES), ethnicity, smoking, alcohol, glucocorticoid exposure, prescription drug use (i.e., antidepressant (SSRI), anti-hypertensive, anti-asthmatic, anti-epileptic, steroids) will be gathered from the medical files of the mothers and from questionnaires completed by the mother. These data will be used as covariates in analyses (T1 to T5) as appropriate.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)