Video-Supported Medication Education for Women Undergoing In Vitro Fertilization (IVF): Quality of Life and Psychosocial Effects

NCT ID: NCT06515275

Last Updated: 2025-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-11

Study Completion Date

2025-07-15

Brief Summary

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Reproductive health problems, particularly infertility, affect 48 million couples globally, ranking as the fifth most serious global obstacle for women. Infertility can lead to significant psychosocial effects, including stress, anxiety, and depression, with women experiencing these impacts more severely than men. In vitro fertilization (IVF) offers a solution but comes with emotional, physical, and psychosocial challenges, particularly for women, who often experience fatigue, headaches, weight gain, and stress. Effective support mechanisms, such as information and education, are crucial in improving the IVF experience. Video-assisted educational programs have shown promise in enhancing knowledge and reducing stress during IVF treatment. However, there is a lack of studies evaluating their impact on the quality of life and psychosocial status of women undergoing IVF. This study aims to examine the effect of video-supported training on drug use, quality of life, and psychosocial status of women during IVF treatment, hypothesizing that it will improve quality of life, increase emotional capacity, and reduce anxiety.

Detailed Description

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Conditions

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Infertility In Vitro Fertilization Psychosocial Support Systems Quality of Life Health Education

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment Randomized Controlled Experimental Design
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
In the single-blind method, subjects do not know which of the experimental or control groups they were selected and therefore which method was applied to them. The researcher knows the subjects selected for the experimental and control groups, and therefore which method was applied to which subjects.

Study Groups

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Experimental Group

Participants will complete a demographic and treatment-related questionnaire. Prior to starting ovulation induction, they will complete the SCREENIVF, STAI, and FertiQol scales. On the first day of ovulation induction, participants will receive face-to-face and video-assisted education on prescribed medications, covering purpose, dose, administration, injection technique, timing, effects, and side effects. After follicle tracking confirms readiness for egg retrieval, participants will receive individual education on the ovulation-triggering medication, followed by QR code-linked educational videos specific to this medication. Post-oocyte aspiration, once sedation effects wear off, participants will complete the SCREENIVF, STAI, and FertiQol scales, along with an Education Satisfaction Evaluation Form.

Group Type EXPERIMENTAL

Education via video (QR code links)

Intervention Type OTHER

Video education on self-administered medications for women undergoing IVF treatment

Control Group

Participants will complete a demographic and treatment-related questionnaire. Before starting ovulation induction, they will complete the SCREENIVF, STAI, and FertiQol scales. On the first day of ovulation induction, participants will receive face-to-face education on medication use, covering purpose, dose, administration, injection technique, timing, effects, and side effects. After ovulation induction, follicle tracking will occur. Upon readiness for egg retrieval, participants will receive individual education on the medication to trigger ovulation. After oocyte aspiration and recovery from sedation, participants will complete the SCREENIVF, STAI, and FertiQol scales, plus an Education Satisfaction Evaluation Form. Control group participants seeking continued treatment after a failed cycle will receive post-study access to video-assisted medication education via QR codes.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Education via video (QR code links)

Video education on self-administered medications for women undergoing IVF treatment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Being female
* Undergoing infertility treatment
* Aged 18-49 years
* Owning a tablet, smartphone, or similar device
* Having internet access
* Undergoing IVF treatment for the first time

Exclusion Criteria

* Previously received controlled ovarian stimulation treatment
* Patients undergoing frozen embryo transfer
* No internet access
* Refusal to participate in the IVF medication teaching session
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Acibadem University

OTHER

Sponsor Role lead

Responsible Party

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Merve Coskun

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Merve Coşkun

Ataşehir, Istanbul, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Facility Contacts

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Merve Coşkun, Phd

Role: primary

+902165004171

Merve Coşkun

Role: backup

References

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European Society of Human Reproduction and Embryology (ESHRE). (2021, August). Factsheet on infertility - prevalence, treatment and fertility decline in Europe.

Reference Type BACKGROUND

Gameiro S, Finnigan A. Long-term adjustment to unmet parenthood goals following ART: a systematic review and meta-analysis. Hum Reprod Update. 2017 May 1;23(3):322-337. doi: 10.1093/humupd/dmx001.

Reference Type BACKGROUND
PMID: 28164236 (View on PubMed)

Ahmadi SM, Shahverdi J, Rezaei M, Bakhtiari M, Sadeghi K, Veisy F, Shahverdi M. The Effect of Behavioral Couple Therapy on the Improvement of Mental Health and Reduction of Marital Conflict in Infertile Couples in Kermanshah: A Randomized Controlled Trial (RCT). J Reprod Infertil. 2019 Jan-Mar;20(1):16-23.

Reference Type BACKGROUND
PMID: 30859078 (View on PubMed)

Barnack-Tavlaris, J. L. (2019). Women's Experiences of Infertility. In J. C. C. Jane M. Ussher, Janette Perz (Ed.), Routledge International Handbook of Women's Sexual and Reproductive Health (pp. 205-220): Routledge.

Reference Type BACKGROUND

Bakhtiyar K, Beiranvand R, Ardalan A, Changaee F, Almasian M, Badrizadeh A, Bastami F, Ebrahimzadeh F. An investigation of the effects of infertility on Women's quality of life: a case-control study. BMC Womens Health. 2019 Sep 4;19(1):114. doi: 10.1186/s12905-019-0805-3.

Reference Type BACKGROUND
PMID: 31484531 (View on PubMed)

Yassa, M., Arslan, E., & Gulbahar, D. S. (2019). Effects of infertility treatment on anxiety and depression levels. Cukurova Medical Journal, 44(2), 410-415.

Reference Type BACKGROUND

Gameiro S, Boivin J, Dancet E, de Klerk C, Emery M, Lewis-Jones C, Thorn P, Van den Broeck U, Venetis C, Verhaak CM, Wischmann T, Vermeulen N. ESHRE guideline: routine psychosocial care in infertility and medically assisted reproduction-a guide for fertility staff. Hum Reprod. 2015 Nov;30(11):2476-85. doi: 10.1093/humrep/dev177. Epub 2015 Sep 7.

Reference Type BACKGROUND
PMID: 26345684 (View on PubMed)

LoGiudice JA, Massaro J. The impact of complementary therapies on psychosocial factors in women undergoing in vitro fertilization (IVF): A systematic literature review. Appl Nurs Res. 2018 Feb;39:220-228. doi: 10.1016/j.apnr.2017.11.025. Epub 2017 Nov 21.

Reference Type BACKGROUND
PMID: 29422163 (View on PubMed)

Pasch LA, Holley SR, Bleil ME, Shehab D, Katz PP, Adler NE. Addressing the needs of fertility treatment patients and their partners: are they informed of and do they receive mental health services? Fertil Steril. 2016 Jul;106(1):209-215.e2. doi: 10.1016/j.fertnstert.2016.03.006. Epub 2016 Mar 24.

Reference Type BACKGROUND
PMID: 27018159 (View on PubMed)

Vause TDR, Allison DJ, Vause T, Tekok-Kilic A, Ditor DS, Min JK. Comparison of a Web-Based Teaching Tool and Traditional Didactic Learning for In Vitro Fertilization Patients: A Preliminary Randomized Controlled Trial. J Obstet Gynaecol Can. 2018 May;40(5):588-594. doi: 10.1016/j.jogc.2017.08.029. Epub 2017 Oct 17.

Reference Type BACKGROUND
PMID: 29054507 (View on PubMed)

Jones CA, Mehta C, Zwingerman R, Liu KE. Fertility patients' use and perceptions of online fertility educational material. Fertil Res Pract. 2020 Jul 18;6:11. doi: 10.1186/s40738-020-00083-2. eCollection 2020.

Reference Type BACKGROUND
PMID: 32695432 (View on PubMed)

Mills R, Ensinger M, Callanan N, Haga SB. Development and Initial Assessment of a Patient Education Video about Pharmacogenetics. J Pers Med. 2017 May 25;7(2):4. doi: 10.3390/jpm7020004.

Reference Type BACKGROUND
PMID: 28587070 (View on PubMed)

Park J, Son W, Park KS, Kang DH, Lee J, Oh CW, Kwon OK, Kim T, Kim CH. Educational and interactive informed consent process for treatment of unruptured intracranial aneurysms. J Neurosurg. 2017 Mar;126(3):825-830. doi: 10.3171/2016.2.JNS151830. Epub 2016 May 6.

Reference Type BACKGROUND
PMID: 27153169 (View on PubMed)

Winter M, Kam J, Nalavenkata S, Hardy E, Handmer M, Ainsworth H, Lee WG, Louie-Johnsun M. The use of portable video media vs standard verbal communication in the urological consent process: a multicentre, randomised controlled, crossover trial. BJU Int. 2016 Nov;118(5):823-828. doi: 10.1111/bju.13595. Epub 2016 Aug 25.

Reference Type BACKGROUND
PMID: 27440499 (View on PubMed)

Bernard AL, Barbour AK, Meernik C, Madeira JL, Lindheim SR, Goodman LR. The impact of an interactive multimedia educational platform on patient comprehension and anxiety during fertility treatment: a randomized controlled trial. F S Rep. 2022 May 22;3(3):214-222. doi: 10.1016/j.xfre.2022.05.006. eCollection 2022 Sep.

Reference Type BACKGROUND
PMID: 36212557 (View on PubMed)

Boivin J, Takefman J, Braverman A. The fertility quality of life (FertiQoL) tool: development and general psychometric properties. Hum Reprod. 2011 Aug;26(8):2084-91. doi: 10.1093/humrep/der171. Epub 2011 Jun 10.

Reference Type BACKGROUND
PMID: 21665875 (View on PubMed)

Verhaak CM, Lintsen AM, Evers AW, Braat DD. Who is at risk of emotional problems and how do you know? Screening of women going for IVF treatment. Hum Reprod. 2010 May;25(5):1234-40. doi: 10.1093/humrep/deq054. Epub 2010 Mar 13.

Reference Type BACKGROUND
PMID: 20228392 (View on PubMed)

Other Identifiers

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2024-8/313

Identifier Type: -

Identifier Source: org_study_id

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