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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
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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.
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:
Exclusion criteria:
• Patients with genetic diseases (PGD patients)
The investigators would like to know more about whether EWI has an effect on:
Furthermore mediators and moderators will be explored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| counselling | Experimental | Does couples in IVF treatment benefit from emotional disclosure |
|
| Control | Active Comparator | Neutral writing exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Expressive writing | Behavioral | 3 consecutive days of writing |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Effect of Expressive Writing Intervention on Fertility Related Stress | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy Rate | How many women achieved pregnancy in each arm | measured at follow-up (t3) 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bobby Zachariae, prof.med., | University of Aarhus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychology, Aarhus University | Aarhus | Jylland | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34949542 | Derived | Philipsen MT, Knudsen UB, Zachariae R, Ingerslev HJ, Hvidt JEM, Frederiksen Y. Sleep, psychological distress, and clinical pregnancy outcome in women and their partners undergoing in vitro or intracytoplasmic sperm injection fertility treatment. Sleep Health. 2022 Apr;8(2):242-248. doi: 10.1016/j.sleh.2021.10.011. Epub 2021 Dec 20. | |
| 28007790 |
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Couples were recruited from November 2010 through July 2012. Recruitment took place at the following three Danish fertility clinics: The Fertility Clinic at Aarhus University Hospital, Skive Fertility Clinic, Skive; Brædstrup Fertility Clinic, Brædstrup.
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| ID | Title | Description |
|---|---|---|
| FG000 | Counselling | Do couples in IVF treatment benefit from emotional disclosure Expressive writing: 3 consecutive days of writing |
| FG001 | Control | Neutral writing exercise Active ctrl: Control |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Counselling | Does couples in IVF treatment benefit from emotional disclosure Expressive writing: 3 consecutive days of writing |
| BG001 | Control | Neutral writing exercise Active ctrl: Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The rows indicate the age dependent on gender |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Effect of Expressive Writing Intervention on Fertility Related Stress | 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. | Couples undergoing IVF or ICSI fertility treatment | Posted | Mean | Standard Deviation | units on a scale | follow-up 2 (3 months) |
|
20 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Counselling | Do couples in IVF treatment benefit from emotional disclosure Expressive writing: 3 consecutive days of writing |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yoon Frederiksen | Aarhus University | +4587565871 | yoonf@psy.au.dk |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| Active ctrl | Behavioral | Control |
|
| Frederiksen Y, O'Toole MS, Mehlsen MY, Hauge B, Elbaek HO, Zachariae R, Ingerslev HJ. The effect of expressive writing intervention for infertile couples: a randomized controlled trial. Hum Reprod. 2017 Feb;32(2):391-402. doi: 10.1093/humrep/dew320. Epub 2016 Dec 21. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Self-reported data | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants |
|
Do couples in IVF treatment benefit from emotional disclosure
Expressive writing: 3 consecutive days of writing
| OG001 | Control | Neutral writing exercise Active ctrl: Control |
|
|
|
| Secondary | Pregnancy Rate | How many women achieved pregnancy in each arm | Posted | Count of Participants | Participants | measured at follow-up (t3) 3 months |
|
|
|
| 0 |
| 108 |
| 0 |
| 108 |
| 0 |
| 108 |
| EG001 | Control | Neutral writing exercise Active ctrl: Control | 0 | 108 | 0 | 108 | 0 | 108 |
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