IVF-ETNCT06590636
Impact of Expressive Touching During Embryo Transfer
A study testing Expressive touching in people with IVF-ET, run by TC Erciyes University at 1 site in Palestinian Territories.
Trial summary
Infertile individuals report psychiatric symptoms and that their levels of anxiety and depression are significantly higher than in fertile controls .Thus,this study aimed to determine the effect of expressive touching during embryo transfer on the anxiety and pregnancy rate. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- IVF-ET
- What is being tested?
- Expressive touching
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 5 Jun 2023to 30 Sep 2023
- 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 25 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Having a diagnosis of primary infertility,
- Being over the age of 25 and under the age of 35
- Able to read and write Arabic,
- Women who will be applied assisted reproductive techniques such as IVF- ICSI-ET,
- Women with the same drugs and protocols used in IVF treatment was included in the study.
Who cannot join
- Women who have problems in understanding and perception,
- Having a diagnosis of secondary infertility wasn\'t included in the study
Trial locations and contacts
1 site in 1 country.
Palestinian Territories1 site
Albasma a private IVF center
Gaza
About this study
Official title: Impact of Expressive Touching During Embryo Transfer on the Anxiety and Pregnancy Rate of Women Undergoing in Vitro Fertilization
Infertile individuals report psychiatric symptoms and that their levels of anxiety and depression are significantly higher than in fertile controls .Thus,this study aimed to determine the effect of expressive touching during embryo transfer on the anxiety and pregnancy rate.
- Conditions
- IVF-ET
- Being tested
- Expressive touching
- Keywords
- Embryo, Expressive Touching, Women, Pregnancy, Anxiety, In Vitro Fertilization
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expressive touchingProcedure or surgery
Woman's anxiety level was measured with the State-Trait Anxiety Inventory scale Following these measurements, expressive touching that lasted 15-20 minutes was performed in the following manner.
The hands of the expressive touching performer warmed to body temperature (should not be cold).
The woman's hand close to the performer was placed between the hands of the expressive touching performer.
The woman's palm was gently grasped with the palms of the expressive touching performer.
The hand below was fixed and the upper part of the woman's hand was gently rubbed with the hand above.
Before and after massaging, the woman's arms and shoulders were touched at intervals.
During the procedure, the woman was called by her name, and verbal communication with the woman was continued by holding her hands firmly and sincerely as if a handshaking done.
Before the woman's discharge from the center, her anxiety level was measured with the State-Trait Anxiety Inventory scale
| Study group | Role | What they receive |
|---|---|---|
| Infertile women | Experimental | Not described Receives: Procedure: Expressive touching |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The State-Trait Anxiety Inventory Scale
The scale is a self-assessment questionnaire and, consists of 40 items rated on 4- point Likert scale. The scale consists of two sub-dimensions: the "state anxiety" has 20 items and is used to determine what is felt at a specific moment under certain conditions, and the "trait anxiety" has 20 items and is used to determine what has been felt in the last seven days. The scale includes reversed and non-reversed items. The score obtained from the reversed items is subtracted from the score obtained from the non-reversed items. Then, 50 points are added to this score for the state anxiety dimension and 35 points for the trait anxiety dimension, giving the total score. The score obtained from the two sub-dimensions ranges between 20 and 80. Higher scores indicate that the anxiety level is high
Measured: Anxiety levels in women were measured using the State-Trait Anxiety Inventory (STAI) both before and after the embryo transfer procedure. The assessments were conducted within 5 to 10 minutes of each other to capture the immediate impact of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start5 Jun 2023
- Primary completion5 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVF-ETStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duha Shaqalaih, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590636
- Sponsor's protocol ID
- 1307/23
- Status last verified
- Sep 2024
- First submitted
- 4 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Expressive Touching During Embryo Transfer on the Anxiety and Pregnancy Rate of Women Undergoing in Vitro Fertilization
- ClinicalTrials.gov ID
- NCT06590636
- Acronym / sponsor ID
- 1307/23
- Conditions
- IVF-ET
- Keywords
- Embryo, Expressive Touching, Women, Pregnancy, Anxiety, In Vitro Fertilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 5 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 19 Sep 2024 (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.
Infertile individuals report psychiatric symptoms and that their levels of anxiety and depression are significantly higher than in fertile controls .Thus,this study aimed to determine the effect of expressive touching during embryo transfer on the anxiety and pregnancy rate.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infertile women | Experimental | Procedure: Expressive touching |
| Control group | No intervention | – |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Having a diagnosis of primary infertility,
- Being over the age of 25 and under the age of 35
- Able to read and write Arabic,
- Women who will be applied assisted reproductive techniques such as IVF- ICSI-ET,
- Women with the same drugs and protocols used in IVF treatment was included in the study.
Key exclusion criteria (2 listed)
- Women who have problems in understanding and perception,
- Having a diagnosis of secondary infertility wasn\'t included in the study
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 |
|---|---|---|
| Expressive touchingWoman's anxiety level was measured with the State-Trait Anxiety Inventory scale Following these measurements, expressive touching that lasted 15-20 minutes was performed in the following manner. The hands of the expressive touching performer warmed to body temperature (should not be cold). The woman's hand close to the performer was placed between the hands of the expressive touching performer. The woman's palm was gently grasped with the palms of the expressive touching performer. The hand below was fixed and the upper part of the woman's hand was gently rubbed with the hand above. Before and after massaging, the woman's arms and shoulders were touched at intervals. During the procedure, the woman was called by her name, and verbal communication with the woman was continued by holding her hands firmly and sincerely as if a handshaking done. Before the woman's discharge from the center, her anxiety level was measured with the State-Trait Anxiety Inventory scale | Procedure or surgery | Infertile women |
Primary outcome
The State-Trait Anxiety Inventory Scale
Time frame: Anxiety levels in women were measured using the State-Trait Anxiety Inventory (STAI) both before and after the embryo transfer procedure. The assessments were conducted within 5 to 10 minutes of each other to capture the immediate impact of the procedure
The scale is a self-assessment questionnaire and, consists of 40 items rated on 4- point Likert scale. The scale consists of two sub-dimensions: the "state anxiety" has 20 items and is used to determine what is felt at a specific moment under certain conditions, and the "trait anxiety" has 20 items and is used to determine what has been felt in the last seven days. The scale includes reversed and non-reversed items. The score obtained from the reversed items is subtracted from the score obtained from the non-reversed items. Then, 50 points are added to this score for the state anxiety dimension and 35 points for the trait anxiety dimension, giving the total score. The score obtained from the two sub-dimensions ranges between 20 and 80. Higher scores indicate that the anxiety level is high
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 19 Sep 2024.
- 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 Expressive touching in people with IVF-ET, run by TC Erciyes University at 1 site in Palestinian Territories.
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 5 inclusion and 2 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 19 Sep 2024. 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 Palestinian Territories. 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?
The State-Trait Anxiety Inventory Scale (time frame: Anxiety levels in women were measured using the State-Trait Anxiety Inventory (STAI) both before and after the embryo transfer procedure. The assessments were conducted within 5 to 10 minutes of each other to capture the immediate impact of the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.