InfertilityNCT05708937
THE EFFECT OF COGNITIVE AWARENESS SUPPORT ON THE PSYCHOSOCIAL STATUS OF WOMEN TREATED FOR INFERTILITY
A study testing Mindfulness based phone app in people with Infertility and Infertility, Female, run by Maltepe University at 1 site in Turkey (Türkiye).
Trial summary
Aim: With the project, mobile application supported cognitive awareness applications in women receiving infertility treatment; The aim of this study was to measure the effect of infertile women on their psychosocial status. Method: It was planned as a randomized controlled study. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infertility, Infertility, Female
- What is being tested?
- Mindfulness based phone app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 May 2021to 20 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having completed the Informed consent form and volunteering to participate in the study
- Not having a psychiatric diagnosis (schizophrenia, bipolar disorder, major depression, anxiety disorders, etc.)
- Beginning or soon to start IVF treatment (starting ovarian stimulation)
- Having a maximum of three previous IVF attempts
- Using a smartphone
- Speaks and understands Turkish
- Being over 18 years old
Who cannot join
- Termination of treatment at any stage
- Failure to transfer embryos
- Leaving work voluntarily
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assistant Proffessor Ph.D.
Aim: With the project, mobile application supported cognitive awareness applications in women receiving infertility treatment; The aim of this study was to measure the effect of infertile women on their psychosocial status.
Method: It was planned as a randomized controlled study. It was aimed to reduce stress and increase awareness by applying mindfulness/cognitive awareness to women undergoing infertility treatment. For this reason, special mindfulness suggestions were created for infertile women by taking the opinion of an expert in the field. Mindfulness suggestions created specifically for women with infertility were recorded. The recordings were varied according to the treatment stages, with an average duration of 40 minutes. These audio recordings were presented with a mobile application developed for infertile women. The mobile application called IVFMind was designed for infertile women. The application consists of mindfulness audio recordings and reading sections. The experimental group (n:17) installed this application on their phones and listened to the audio recordings regularly. Cognitive awareness (BIFO), depression-anxiety (DASS 21), infertility self-efficacy and fertility adjustment scales were administered to the experimental and control groups (N:34). Scales were done as pre-test and post-test. The mobile application evaluation form was filled in the experimental group.
Read the detailed description
Infertility is a process with social, cultural and psychological interaction as well as physical condition. Infertility is a perceived loss for women, men and families. It requires adapting to a childless lifestyle and developing a coping mechanism with the difficulties encountered (Lee, Choi, Chan , Chan , \& Ernest, 2009). Infertility treatments are stressful, physically painful and financially demanding life crises for most couples (Boivin, Griffiths, \& Venetis, 2011). It is not enough that the nursing care that women who experience such a complex psychosocial process will receive during the same complex treatment process is only physical care. For this reason, individuals in the diagnosis and treatment process of infertility, especially women, need social support (Blevins, 2011).
Providing psychosocial support to infertile patients is one of the important tasks of nursing care.
There are studies in the literature showing that mindfulness-based care is an effective method for improving psychological health (such as quality of life, stress, marital adjustment) in women in infertility clinics (Fard, Kalantarkousheh, \& Faramarzi, 2018) (Lunn \& Sherratt, 2013) (Shargh, et al. , 2016) (Hosseini, et al., 2020). A study of the mindfulness-based care intervention found increases in awareness levels, self-compassion, and coping strategies in infertile women during their first IVF treatment. Thus, it was found to improve fertility-related quality of life and pregnancy rates (Li, Long, Liu, He, \& Li, 2016).
With this project, a mobile application was developed to provide mindfulness-based psychosocial support to infertile women. The mobile application contains mindfulness-based audio recordings developed specifically for infertility. Participants listened regularly (twice a day) to meditation appropriate to the treatment phase.
Psychosocial assessments (pretest and posttest) were applied to measure the benefit of this practice on participants.
The psychosocial status of women receiving infertility treatment was measured through the scales used, and the effect of mobile application and mindfulness nursing support on the participants was evaluated.
- Conditions
- Infertility, Infertility, Female
- Being tested
- Mindfulness based phone app
- Keywords
- Infertility, Female Infertility, Mindfulness
- Medical subject headings
- Infertility, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness based phone appBehavioural
Creating mindfulness-based suggestions for infertile women:
Mindfulness-based content was created by taking the opinions of experts in the fields of women's health nursing, psychology and linguistics. It consists of 6 different parts. The content of meditation that the patient will apply according to the treatment stage is different. Infertility mindfulness departments; "Breath Awareness, Body \& Uterus Awareness, Needle Therapy and Ovarian Awareness, Pre-Egg Collection (OPU) Diaphragm Breathing, Pre-embryo Transfer Uterine Awareness, Embryo and Uterine Awareness (Post transfer)".
Audio recordings of mindfulness-themed meditation content:
After the meditation contents are planned; the sound recording was taken with a professional recorder (Sony ICD-PX470). The audio recordings taken were professionally edited by the expert. Mp3 recordings were created by adding background music to sound recordings in computer environment. Audio recordings of mindfulness-themed meditation content
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Experimental group participants used the mindfulness mobile application. Then, the psychosocial status of the participants was measured with scales. Receives: Behavioral: Mindfulness based phone app |
| Control group | No intervention | The control group participants did not receive any intervention. Classical care was applied. Then, the psychosocial status of the participants was measured with scales. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Information Form
This form, prepared by the researcher, consists of 21 items. It questions socio-demographic information such as age, educational status, occupation, duration of marriage, and infertility history, obstetric history and chronic disease status.
Measured: 6 weeks
Cognitive Awareness Scale
Developed by Brown and Ryan in 2003, the scale aims to measure awareness and attention to momentary experiences in daily life. It gives the total score with its single factor structure, as the score increases, the level of conscious awareness increases. Factor loads range from 27 to 78. It is answered on a 15-item 6-point Likert-type scale (from "almost always" to "almost never"). It aims to determine how often they experience their experiences automatically, without paying attention to the present moment. As the scores obtained from the scale increase; It is understood that cognitive awareness is high. The internal consistency coefficient of the scale is 82
Measured: 1 year
Infertility Self-Efficacy Scale
The original titled Infertility Self-Efficacy Scale was found in 2006 by Cousineau et al. It was developed to evaluate the self-efficacy perceptions of individuals related to infertility about their emotional, cognitive and behavioral skills.
The nine-point Likert-type scale (1- not at all important and 9- very important) consists of a total of 16 items. In 2006, a 10-item short form was created. All statements in the scale are positive. Scores ranging from 10 to 90 are taken from the short form of the scale. The higher the score, the higher the perception of self-efficacy. In the original of the scale, the reliability coefficient was determined as α:94. The scale is unidimensional and scores are between 8 and 32. The higher the score, the higher the perception of self-efficacy.
Measured: 1 year
Depression Anxiety Stress Short Scale (DASS 21)
Depression anxiety stress short scale (DASS 21) consists of 21 items aiming to measure the level of "depression, anxiety and stress" under three headings. In the normal sample, the test-retest correlation coefficients were found to be r=0.68 for the depression subscale, r=0.66 for the anxiety subscale, and r=0.61 for the stress subscale. This scale is a 4-point Likert-type scale and measures "depression, stress and anxiety dimensions". If the individual scores 5 points or more from the depression sub-dimension, 4 points or more from anxiety, and 8 points or more from stress, it indicates that he or she has a related problem.
Measured: 1 year
Mobile Application Evaluation Results
It was prepared by the researcher and aims to evaluate users' satisfaction with the mobile application. The usability of the mobile application is aimed at getting the opinions of the patients about the topics to be suggested for the mobile application. The first 4 items of the 6-item form have a 3-point Likert feature (1-yes, 2-no, 3-I'm not sure), while the other 2 items ask open-ended questions about the topics that users want to suggest.
Measured: 1 year
Fertility Adjustment Scale
The scale, originally named Fertility Adjustment, was developed by Glover et al in 1999 to standardize the measurement of psychological adjustment in infertility. Infertility compliance; It is considered as a concept that includes behavioral, cognitive and emotional aspects. The infertility adjustment scale can be used as a useful tool to evaluate the effect of the treatment process on the psychosocial adjustment of individuals and their psychological needs. The scale is a six-point Likert-type, 12-item scale. The minimum scale score is 12 and the maximum score is 72. The items were balanced in order not to affect the answers in terms of positive and negative statements. Positive items are reverse scored. A high infertility compliance scale score indicates inadequate compliance. In the original of the scale, the reliability coefficient was determined as α.85.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start21 May 2021
- Primary completion16 Dec 2021
- Study completion20 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maltepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özen İnam, Maltepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708937
- Sponsor's protocol ID
- E-74555795-050.01.04-52289
- Status last verified
- Jan 2023
- First submitted
- 19 Dec 2022
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Inam O, Satilmis IG. The effect of mindfulness-based nursing support on the psychosocial status of women receiving infertility treatment: a randomized controlled trial. BMC Womens Health. 2025 Mar 20;25(1):127. doi: 10.1186/s12905-025-03659-6.
PubMed 40114156
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assistant Proffessor Ph.D.
- ClinicalTrials.gov ID
- NCT05708937
- Acronym / sponsor ID
- E-74555795-050.01.04-52289
- Conditions
- Infertility, Infertility, Female
- Keywords
- Infertility, Female Infertility, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Maltepe UniversityUniversity, hospital or other
- Study start
- 21 May 2021 (actual)
- Primary completion
- 16 Dec 2021 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim: With the project, mobile application supported cognitive awareness applications in women receiving infertility treatment; The aim of this study was to measure the effect of infertile women on their psychosocial status.
Method: It was planned as a randomized controlled study. It was aimed to reduce stress and increase awareness by applying mindfulness/cognitive awareness to women undergoing infertility treatment. For this reason, special mindfulness suggestions were created for infertile women by taking the opinion of an expert in the field. Mindfulness suggestions created specifically for women with infertility were recorded. The recordings were varied according to the treatment stages, with an average duration of 40 minutes. These audio recordings were presented with a mobile application developed for infertile women. The mobile application called IVFMind was designed for infertile women. The application consists of mindfulness audio recordings and reading sections. The experimental group (n:17) installed this application on their phones and listened to the audio recordings regularly. Cognitive awareness (BIFO), depression-anxiety (DASS 21), infertility self-efficacy and fertility adjustment scales were administered to the experimental and control groups (N:34). Scales were done as pre-test and post-test. The mobile application evaluation form was filled in the experimental group.
Detailed description
Infertility is a process with social, cultural and psychological interaction as well as physical condition. Infertility is a perceived loss for women, men and families. It requires adapting to a childless lifestyle and developing a coping mechanism with the difficulties encountered (Lee, Choi, Chan , Chan , \& Ernest, 2009). Infertility treatments are stressful, physically painful and financially demanding life crises for most couples (Boivin, Griffiths, \& Venetis, 2011). It is not enough that the nursing care that women who experience such a complex psychosocial process will receive during the same complex treatment process is only physical care. For this reason, individuals in the diagnosis and treatment process of infertility, especially women, need social support (Blevins, 2011).
Providing psychosocial support to infertile patients is one of the important tasks of nursing care.
There are studies in the literature showing that mindfulness-based care is an effective method for improving psychological health (such as quality of life, stress, marital adjustment) in women in infertility clinics (Fard, Kalantarkousheh, \& Faramarzi, 2018) (Lunn \& Sherratt, 2013) (Shargh, et al. , 2016) (Hosseini, et al., 2020). A study of the mindfulness-based care intervention found increases in awareness levels, self-compassion, and coping strategies in infertile women during their first IVF treatment. Thus, it was found to improve fertility-related quality of life and pregnancy rates (Li, Long, Liu, He, \& Li, 2016).
With this project, a mobile application was developed to provide mindfulness-based psychosocial support to infertile women. The mobile application contains mindfulness-based audio recordings developed specifically for infertility. Participants listened regularly (twice a day) to meditation appropriate to the treatment phase.
Psychosocial assessments (pretest and posttest) were applied to measure the benefit of this practice on participants.
The psychosocial status of women receiving infertility treatment was measured through the scales used, and the effect of mobile application and mindfulness nursing support on the participants was evaluated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Mindfulness based phone appExperimental group participants used the mindfulness mobile application. Then, the psychosocial status of the participants was measured with scales. |
| Control group | No intervention | –The control group participants did not receive any intervention. Classical care was applied. Then, the psychosocial status of the participants was measured with scales. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Having completed the Informed consent form and volunteering to participate in the study
- Not having a psychiatric diagnosis (schizophrenia, bipolar disorder, major depression, anxiety disorders, etc.)
- Beginning or soon to start IVF treatment (starting ovarian stimulation)
- Having a maximum of three previous IVF attempts
- Using a smartphone
Key exclusion criteria (3 listed)
- Termination of treatment at any stage
- Failure to transfer embryos
- Leaving work voluntarily
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness based phone appCreating mindfulness-based suggestions for infertile women: Mindfulness-based content was created by taking the opinions of experts in the fields of women's health nursing, psychology and linguistics. It consists of 6 different parts. The content of meditation that the patient will apply according to the treatment stage is different. Infertility mindfulness departments; "Breath Awareness, Body \& Uterus Awareness, Needle Therapy and Ovarian Awareness, Pre-Egg Collection (OPU) Diaphragm Breathing, Pre-embryo Transfer Uterine Awareness, Embryo and Uterine Awareness (Post transfer)". Audio recordings of mindfulness-themed meditation content: After the meditation contents are planned; the sound recording was taken with a professional recorder (Sony ICD-PX470). The audio recordings taken were professionally edited by the expert. Mp3 recordings were created by adding background music to sound recordings in computer environment. Audio recordings of mindfulness-themed meditation content | Behavioural | Experimental group |
Primary outcome
Personal Information Form
Time frame: 6 weeks
This form, prepared by the researcher, consists of 21 items. It questions socio-demographic information such as age, educational status, occupation, duration of marriage, and infertility history, obstetric history and chronic disease status.
Cognitive Awareness Scale
Time frame: 1 year
Developed by Brown and Ryan in 2003, the scale aims to measure awareness and attention to momentary experiences in daily life. It gives the total score with its single factor structure, as the score increases, the level of conscious awareness increases. Factor loads range from 27 to 78. It is answered on a 15-item 6-point Likert-type scale (from "almost always" to "almost never"). It aims to determine how often they experience their experiences automatically, without paying attention to the present moment. As the scores obtained from the scale increase; It is understood that cognitive awareness is high. The internal consistency coefficient of the scale is 82
Infertility Self-Efficacy Scale
Time frame: 1 year
The original titled Infertility Self-Efficacy Scale was found in 2006 by Cousineau et al. It was developed to evaluate the self-efficacy perceptions of individuals related to infertility about their emotional, cognitive and behavioral skills. The nine-point Likert-type scale (1- not at all important and 9- very important) consists of a total of 16 items. In 2006, a 10-item short form was created. All statements in the scale are positive. Scores ranging from 10 to 90 are taken from the short form of the scale. The higher the score, the higher the perception of self-efficacy. In the original of the scale, the reliability coefficient was determined as α:94. The scale is unidimensional and scores are between 8 and 32. The higher the score, the higher the perception of self-efficacy.
Depression Anxiety Stress Short Scale (DASS 21)
Time frame: 1 year
Depression anxiety stress short scale (DASS 21) consists of 21 items aiming to measure the level of "depression, anxiety and stress" under three headings. In the normal sample, the test-retest correlation coefficients were found to be r=0.68 for the depression subscale, r=0.66 for the anxiety subscale, and r=0.61 for the stress subscale. This scale is a 4-point Likert-type scale and measures "depression, stress and anxiety dimensions". If the individual scores 5 points or more from the depression sub-dimension, 4 points or more from anxiety, and 8 points or more from stress, it indicates that he or she has a related problem.
Mobile Application Evaluation Results
Time frame: 1 year
It was prepared by the researcher and aims to evaluate users' satisfaction with the mobile application. The usability of the mobile application is aimed at getting the opinions of the patients about the topics to be suggested for the mobile application. The first 4 items of the 6-item form have a 3-point Likert feature (1-yes, 2-no, 3-I'm not sure), while the other 2 items ask open-ended questions about the topics that users want to suggest.
Fertility Adjustment Scale
Time frame: 1 year
The scale, originally named Fertility Adjustment, was developed by Glover et al in 1999 to standardize the measurement of psychological adjustment in infertility. Infertility compliance; It is considered as a concept that includes behavioral, cognitive and emotional aspects. The infertility adjustment scale can be used as a useful tool to evaluate the effect of the treatment process on the psychosocial adjustment of individuals and their psychological needs. The scale is a six-point Likert-type, 12-item scale. The minimum scale score is 12 and the maximum score is 72. The items were balanced in order not to affect the answers in terms of positive and negative statements. Positive items are reverse scored. A high infertility compliance scale score indicates inadequate compliance. In the original of the scale, the reliability coefficient was determined as α.85.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Derived from this study: PubMed 40114156Inam O, Satilmis IG. The effect of mindfulness-based nursing support on the psychosocial status of women receiving infertility treatment: a randomized controlled trial. BMC Womens Health. 2025 Mar 20;25(1):127. doi: 10.1186/s12905-025-03659-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness based phone app in people with Infertility and Infertility, Female, run by Maltepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal Information Form (time frame: 6 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05708937, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.