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Involuntary Childlessness and Stress Management

14. juni 2021 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

298

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 45 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • heterosexual couples lesbian couples

Exclusion Criteria:

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: counselling
Does couples in IVF treatment benefit from emotional disclosure
3 consecutive days of writing
Andre navne:
  • EWI
Aktiv komparator: Control
Neutral writing exercise
Control

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Effect of Expressive Writing Intervention on Fertility Related Stress
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pregnancy Rate
Tidsramme: measured at follow-up (t3) 3 months
How many women achieved pregnancy in each arm
measured at follow-up (t3) 3 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2010

Primær færdiggørelse (Faktiske)

1. december 2012

Studieafslutning (Faktiske)

1. december 2012

Datoer for studieregistrering

Først indsendt

9. juli 2010

Først indsendt, der opfyldte QC-kriterier

20. august 2010

Først opslået (Skøn)

23. august 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juni 2021

Sidst verificeret

1. juni 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EWI-2008-41-1869

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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Kliniske forsøg med Expressive writing

Abonner