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Involuntary Childlessness and Stress Management

14 juni 2021 uppdaterad av: Yoon Frederiksen, University of Aarhus

A Randomized Controlled Intervention Study: The Effect of Expressive Writing on Psychosocial Stress and Pregnancy Results With Couples Undergoing In Vitro Fertility(IVF) Treatment Due to Involuntary Childlessness.

Many couples experience involuntary childlessness and seek treatment at fertility clinics. Going through treatment procedures can be very challenging, time consuming and emotionally demanding.

Psychosocial intervention might have a soothing and healing effect on both behavior as well on physical matters. Hence, the investigators would like to investigate whether Expressive Writing Intervention (EWI) has an effect on stress management as well as on the pregnancy rate for couples who are going through fertility treatment.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

Background:

Around 10-14 % of all couples are experiencing involuntary childlessness. Most of these couples will be referred to the public health clinics in order to receive help by means of fertility treatment e.g. in vitro fertility (IVF) and numbers from the National board of Health indicates that the number is rising. It is well known that involuntary childlessness pose an enduring psychosocial burden and strain with feelings of hopelessness, despair, anger and frustration as well as anxiety and sadness. Much research points out that couples that receive IVF treatment to a great extent often experience stress and strong emotional oscillations during the treatment procedures. Some studies indicate that negative feelings as described above might have a negative impact on the chances of becoming pregnant. In spite of these findings there are only conducted very few controlled studies of intervention with this patient group, which might explain why it is still unclear whether infertile couples can benefit from therapeutic intervention.

A growing number of studies in the area of health psychology has suggested that interventions where the participants has the opportunity to express themselves in writing about feelings, so-called Expressive Writing Intervention (EWI) seem to have a positive effect on physical health as well as mental well-being.

Methods:

Couples starting with their IVF treatment at the Fertility Clinic, Skejby Hospital will be invited to participate in the research project. Approximately 400 couples are expected to begin treatment during a one year period (We would like to enrol at least 144 couples). They will be randomized into a EWI group (writing about fertility related topics - emotional disclosure) and a control group (writing about neutral topics non-emotional disclosure).

Inclusion criteria:

  • Heterosexual couples as well as Homosexual couples
  • 1st, 2nd and 3rd treatment cycles
  • Can read and understand Danish
  • Aged 18-40 years

Exclusion criteria:

• Patients with genetic diseases (PGD patients)

The investigators would like to know more about whether EWI has an effect on:

  1. The extent of psychosocial strain - does change happen in life satisfaction, emotional state and reactions, as well as with thoughts about childlessness and treatment.
  2. The result of the IVF treatment (pregnancy/non pregnancy)
  3. The adaptation to the (negative) treatment outcome - the impact of having participated in an EWI intervention group.

Furthermore mediators and moderators will be explored.

Studietyp

Interventionell

Inskrivning (Faktisk)

298

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Jylland
      • Aarhus, Jylland, Danmark, 8000
        • Department of Psychology, Aarhus University

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 45 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • heterosexual couples lesbian couples

Exclusion Criteria:

  • couples; where one of them suffers from a genetic disease

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: counselling
Does couples in IVF treatment benefit from emotional disclosure
3 consecutive days of writing
Andra namn:
  • EWI
Aktiv komparator: Control
Neutral writing exercise
Control

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The Effect of Expressive Writing Intervention on Fertility Related Stress
Tidsram: follow-up 2 (3 months)
The COMPI 14-item self-rating instrument has been developed to capture specific thoughts and feelings in relation to involuntarily childlessness, which may lead to distress on 4-point and 5-point Likert scales. Responses cover personal, social, and marital domains with total scores ranging between 14 - 38, and higher scores indicating higher levels of infertility-related distress. Internal consistency (Cronbach's alpha) in the present study was 0.89 and the baseline to post-intervention test-retest correlation was 0.84. For the sub-domains the reliability of the scales were as follows; personal domain α=0.86, social domain α=0.83 and marital domain α=0.73.
follow-up 2 (3 months)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Pregnancy Rate
Tidsram: measured at follow-up (t3) 3 months
How many women achieved pregnancy in each arm
measured at follow-up (t3) 3 months

Samarbetspartners och utredare

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Samarbetspartners

Utredare

  • Huvudutredare: Bobby Zachariae, prof.med.,, Department of Psychology, Aarhus University

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 november 2010

Primärt slutförande (Faktisk)

1 december 2012

Avslutad studie (Faktisk)

1 december 2012

Studieregistreringsdatum

Först inskickad

9 juli 2010

Först inskickad som uppfyllde QC-kriterierna

20 augusti 2010

Första postat (Uppskatta)

23 augusti 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

16 juni 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 juni 2021

Senast verifierad

1 juni 2021

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • EWI-2008-41-1869

Plan för individuella deltagardata (IPD)

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NEJ

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