AnxietyNCT07835464
STOP-4P for Reducing Anxiety Before Amniocentesis
A study testing STOP4P and Informational Video and Supportive Activities in people with Anxiety, run by Hung Vuong Hospital at 1 site in Vietnam.
Trial summary
The goal of this clinical trial is to learn if STOP-4P can lower anxiety in pregnant women having amniocentesis. Amniocentesis is a prenatal test. A doctor uses a needle to collect a small amount of fluid around the baby. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- STOP4P and Informational Video and Supportive Activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Sep 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant women in the second trimester who are scheduled to undergo diagnostic amniocentesis at Hung Vuong Hospital.
- Able to read and understand Vietnamese, complete the study questionnaires, and follow study instructions.
- Willing to participate and provide written informed consent after receiving a full explanation of the study.
Who cannot join
- Previous diagnosis of a psychiatric disorder, such as generalized anxiety disorder, major depression, or schizophrenia.
- Current use of psychiatric medication or receipt of psychological intervention during the current pregnancy.
- Unable to understand or complete the study questionnaires because of cognitive limitations.
- Obstetric emergency at the time of enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site
Hung Vuong Hospital
Ho Chi Minh City, Ho Chi Minh, 70000
Thong Nguyen, +84 903194666, bsngvanthong@gmail.com
About this study
Official title: Effectiveness of STOP-4P in Reducing Anxiety Among Pregnant Women Undergoing Amniocentesis: A Randomized Controlled Trial at Hung Vuong Hospital
The goal of this clinical trial is to learn if STOP-4P can lower anxiety in pregnant women having amniocentesis.
Amniocentesis is a prenatal test. A doctor uses a needle to collect a small amount of fluid around the baby.
Read more
The main question this trial aims to answer is: Does STOP-4P lower anxiety compared with other forms of support and routine care?
Researchers will compare three groups: (1) The STOP-4P group will receive routine care, watch a short video about amniocentesis, take part in simple support activities, and practice STOP-4P before the procedure, (2) The control group will receive the same care, video, and support activities but will not practice STOP-4P and (3) The observational group will receive routine care only.
Participants in the STOP-4P and control groups will be assigned at random. Those in the observational group will be enrolled separately without random assignment.
Researchers will also look at well-being, pain, heart rate, and blood pressure.
Participants will: (1) Answer short questions about anxiety and well-being before amniocentesis and 30 minutes after the procedure, (2) Have their heart rate and blood pressure measured before amniocentesis, at the start of the procedure, and 30 minutes afterward, (3) Complete the activities assigned to their study group and (4) Rate the pain they felt during amniocentesis.
After the main study assessments are completed, all participants will be offered access to STOP-4P and may practice it at home if they choose.
About 2 weeks after amniocentesis, the study team will record the test result, any complications, and how often participants practiced STOP-4P at home. Participants can also talk with the study team about psychological or medical concerns if needed.
Read the detailed description
Amniocentesis may cause short-term anxiety because pregnant women may worry about the procedure, possible pain or complications, fetal safety, and uncertainty about the test result. The waiting period before amniocentesis was chosen as the intervention window because these concerns are already present before the procedure. It also gives participants time to receive a brief psychological intervention with minimal disruption to routine clinical care.
At enrollment, participants in all three study groups are stratified according to the clinical indication for amniocentesis. Different diagnoses and indications may be associated with different levels of anxiety before the procedure. Stratification helps control these baseline differences and improves comparability among the groups within each stratum before the next group allocation steps.
The protocol also includes a non-randomized observational comparison group receiving routine care alone. This group is enrolled during separate prespecified study sessions. Including this group helps distinguish the added effect of STOP-4P from the effects of other study-related supportive activities and from routine care alone.
All participants are offered access to STOP-4P after the main post-procedure assessment has been completed. This delayed access allows participants who did not receive STOP-4P before amniocentesis to use it while waiting for the test result, without affecting the main study comparison.
Anxiety and well-being are not reassessed at the two-week follow-up because participants' emotional responses may be strongly influenced by the amniocentesis result, especially if the result is abnormal. The later follow-up therefore focuses on clinical information and the use of STOP-4P rather than on evaluating its main anxiety-reduction effect.
- Conditions
- Anxiety
- Being tested
- STOP4P, Informational Video and Supportive Activities
- Keywords
- Amniocentesis, Psychological intervention
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STOP4PBehavioural
STOP-4P is a brief, web-based psychological intervention delivered in an interactive, game-like format and completed in about 10 minutes. It includes eight steps: (1) rating the current emotional state on a 1-10 scale; (2) tapping a virtual bell as a cue to stop and pause briefly; (3) practicing slow breathing with a longer exhalation; (4) noticing areas of discomfort or tension in the body, then relaxing the whole body from head to toe; (5) identifying the current emotion by selecting the closest match from six basic emotions; (6) noticing a worrying thought and imagining letting it go; (7) reconnecting with the baby and writing a short loving message to the baby; and (8) rating the emotional state again on the same 1-10 scale. Participants complete STOP-4P while waiting for amniocentesis.
Informational Video and Supportive ActivitiesBehavioural
Participants watch a short informational video explaining the amniocentesis procedure. They then write a wish for their baby to place on the "Wish Tree" and create a card for themselves or their baby. These brief activities are intended to provide information and supportive emotional expression before amniocentesis.
| Study group | Role | What they receive |
|---|---|---|
| STOP-4P With Video and Supportive Activities | Experimental | Participants receive routine care, watch a short informational video about amniocentesis, complete simple supportive activities, and practice the web-based STOP-4P intervention before amniocentesis. Receives: Behavioral: STOP4P |
| Video and Supportive Activities Without STOP-4P | Other | Participants receive routine care, watch the same informational video about amniocentesis, and complete the same supportive activities as the STOP-4P group, but do not practice STOP-4P before amniocentesis. Receives: Behavioral: Informational Video and Supportive Activities |
| Routine Care Only | No intervention | Participants receive routine care only before the main post-procedure assessment and do not receive the study video, supportive activities, or STOP-4P during this period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in State and Trait Anxiety Scores Before and After Amniocentesis
Anxiety is assessed using the 10-item short form of the State-Trait Anxiety Inventory (STAI). It includes two five-item subscales: state anxiety (STAIS-5) and trait anxiety (STAIT-5). Each subscale has a score range of 5 to 20, with higher scores indicating greater anxiety.
Both subscales are scored before amniocentesis and 30 minutes after the procedure. For each subscale, the change is calculated as the score after the procedure minus the score before the procedure. A negative change indicates a decrease in anxiety.
Changes in state and trait anxiety scores will be compared separately among the STOP-4P, control, and observational groups.
Measured: From the waiting period before amniocentesis to 30 minutes after amniocentesis.
Secondary outcomes (3)
Well-being Scores Before and After Amniocentesis
Well-being is assessed using a one-item measure adapted from the Cantril Self-Anchoring Striving Scale. Scores range from 1 to 10, with higher scores indicating greater well-being and a more positive emotional state. Scores are measured before amniocentesis and 30 minutes after the procedure and compared among the STOP-4P, control, and observational groups.
Measured: During the waiting period before amniocentesis and 30 minutes after amniocentesis.
Pain Intensity After Amniocentesis Measured by the Visual Analog Scale
Participants rate the pain they experienced during amniocentesis using a Visual Analog Scale (VAS) ranging from 0 to 10. A score of 0 indicates no pain, and 10 indicates the worst pain imaginable. Higher scores indicate greater perceived pain. Scores will be compared among the STOP-4P, control, and observational groups.
Measured: 30 minutes after amniocentesis
Changes in Heart Rate and Blood Pressure at Three Time Points
Heart rate is measured in beats per minute at three time points: during the waiting period before amniocentesis, when the participant gets onto the procedure table, and 30 minutes after amniocentesis. Systolic and diastolic blood pressure are measured at the same three time points, and mean arterial pressure (MAP) is calculated at each time point.
For each participant, two changes are calculated separately for heart rate and blood pressure: the value when the participant gets onto the procedure table minus the value during the waiting period, and the value 30 minutes after amniocentesis minus the value during the waiting period. These changes will be compared among the STOP-4P, control, and observational groups.
Measured: During the waiting period before amniocentesis; when the participant gets onto the procedure table; and 30 minutes after amniocentesis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (78)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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
- Parallel groups
- Model description
- The study includes two parallel randomized groups and one additional non-randomized observational comparison group. Participants in all three groups are stratified by clinical indication for amniocentesis. Participants in the randomized component are assigned 1:1 to the STOP-4P or control group, while the observational group is enrolled separately during prespecified study sessions.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hung Vuong Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nguyen Van Thong, Hung Vuong Hospital
- Investigators
- Thong V Nguyen, Principal investigator, Hung Vuong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835464
- Sponsor's protocol ID
- HV-STOP4P-AMNIO-2026
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cantril H. The pattern of human concerns. New Brunswick (NJ): Rutgers University Press; 1965.
Cohen J. Statistical power analysis for the behavioral sciences. 2nd ed. Hillsdale (NJ): Lawrence Erlbaum Associates; 1988.
Raju NN, Naga Pavan Kumar KSVR, Nihal G. Clinical Practice Guidelines for Assessment and Management of Anxiety and Panic Disorders in Emergency Setting. Indian J Psychiatry. 2023 Feb;65(2):181-185. doi: 10.4103/indianjpsychiatry.indianjpsychiatry_489_22. Epub 2023 Jan 30. No abstract available.
PubMed 37063628Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.
PubMed 22588748Đinh Quang Hải, Nguyễn Hoài Bắc. Đặc điểm rối loạn lo âu trên thang điểm STAI-5 ở người bệnh viêm tinh hoàn, mào tinh hoàn điều trị nội trú tại Bệnh viện Đại học Y Hà Nội. Tạp chí Nghiên cứu Y học. 2024;185(12):121-128. doi:10.52852/tcncyh.v185i12.2818.
Zsido AN, Teleki SA, Csokasi K, Rozsa S, Bandi SA. Development of the short version of the spielberger state-trait anxiety inventory. Psychiatry Res. 2020 Sep;291:113223. doi: 10.1016/j.psychres.2020.113223. Epub 2020 Jun 12.
PubMed 32563747Spielberger CD, Gorsuch RL, Lushene RE. Manual for the State-Trait Anxiety Inventory. Palo Alto (CA): Consulting Psychologists Press; 1970.
Leutenegger V, Grylka-Baeschlin S, Wieber F, Daly D, Pehlke-Milde J. The effectiveness of skilled breathing and relaxation techniques during antenatal education on maternal and neonatal outcomes: a systematic review. BMC Pregnancy Childbirth. 2022 Nov 19;22(1):856. doi: 10.1186/s12884-022-05178-w.
PubMed 36402944Bandura A. Self-efficacy: the exercise of control. New York: W.H. Freeman; 1997.
Rooney T, Sharpe L, Todd J, Richmond B, Colagiuri B. The relationship between expectancy, anxiety, and the nocebo effect: a systematic review and meta-analysis with recommendations for future research. Health Psychol Rev. 2023 Dec;17(4):550-577. doi: 10.1080/17437199.2022.2125894. Epub 2022 Oct 7.
PubMed 36111435Corsi N, Colloca L. Placebo and Nocebo Effects: The Advantage of Measuring Expectations and Psychological Factors. Front Psychol. 2017 Mar 6;8:308. doi: 10.3389/fpsyg.2017.00308. eCollection 2017.
PubMed 28321201Woolhouse H, Mercuri K, Judd F, Brown SJ. Antenatal mindfulness intervention to reduce depression, anxiety and stress: a pilot randomised controlled trial of the MindBabyBody program in an Australian tertiary maternity hospital. BMC Pregnancy Childbirth. 2014 Oct 25;14:369. doi: 10.1186/s12884-014-0369-z.
PubMed 25343848Dhillon A, Sparkes E, Duarte RV. Mindfulness-Based Interventions During Pregnancy: a Systematic Review and Meta-analysis. Mindfulness (N Y). 2017;8(6):1421-1437. doi: 10.1007/s12671-017-0726-x. Epub 2017 Apr 17.
PubMed 29201244Tabibnia G, Lieberman MD, Craske MG. The lasting effect of words on feelings: words may facilitate exposure effects to threatening images. Emotion. 2008 Jun;8(3):307-17. doi: 10.1037/1528-3542.8.3.307.
PubMed 18540747Lieberman MD, Inagaki TK, Tabibnia G, Crockett MJ. Subjective responses to emotional stimuli during labeling, reappraisal, and distraction. Emotion. 2011 Jun;11(3):468-80. doi: 10.1037/a0023503.
PubMed 21534661
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of STOP-4P in Reducing Anxiety Among Pregnant Women Undergoing Amniocentesis: A Randomized Controlled Trial at Hung Vuong Hospital
- ClinicalTrials.gov ID
- NCT07835464
- Acronym / sponsor ID
- HV-STOP4P-AMNIO-2026
- Conditions
- Anxiety
- Keywords
- Amniocentesis, Psychological intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Hung Vuong HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Sep 2026 (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.
The goal of this clinical trial is to learn if STOP-4P can lower anxiety in pregnant women having amniocentesis.
Amniocentesis is a prenatal test. A doctor uses a needle to collect a small amount of fluid around the baby.
The main question this trial aims to answer is: Does STOP-4P lower anxiety compared with other forms of support and routine care?
Researchers will compare three groups: (1) The STOP-4P group will receive routine care, watch a short video about amniocentesis, take part in simple support activities, and practice STOP-4P before the procedure, (2) The control group will receive the same care, video, and support activities but will not practice STOP-4P and (3) The observational group will receive routine care only.
Participants in the STOP-4P and control groups will be assigned at random. Those in the observational group will be enrolled separately without random assignment.
Researchers will also look at well-being, pain, heart rate, and blood pressure.
Participants will: (1) Answer short questions about anxiety and well-being before amniocentesis and 30 minutes after the procedure, (2) Have their heart rate and blood pressure measured before amniocentesis, at the start of the procedure, and 30 minutes afterward, (3) Complete the activities assigned to their study group and (4) Rate the pain they felt during amniocentesis.
After the main study assessments are completed, all participants will be offered access to STOP-4P and may practice it at home if they choose.
About 2 weeks after amniocentesis, the study team will record the test result, any complications, and how often participants practiced STOP-4P at home. Participants can also talk with the study team about psychological or medical concerns if needed.
Detailed description
Amniocentesis may cause short-term anxiety because pregnant women may worry about the procedure, possible pain or complications, fetal safety, and uncertainty about the test result. The waiting period before amniocentesis was chosen as the intervention window because these concerns are already present before the procedure. It also gives participants time to receive a brief psychological intervention with minimal disruption to routine clinical care.
At enrollment, participants in all three study groups are stratified according to the clinical indication for amniocentesis. Different diagnoses and indications may be associated with different levels of anxiety before the procedure. Stratification helps control these baseline differences and improves comparability among the groups within each stratum before the next group allocation steps.
The protocol also includes a non-randomized observational comparison group receiving routine care alone. This group is enrolled during separate prespecified study sessions. Including this group helps distinguish the added effect of STOP-4P from the effects of other study-related supportive activities and from routine care alone.
All participants are offered access to STOP-4P after the main post-procedure assessment has been completed. This delayed access allows participants who did not receive STOP-4P before amniocentesis to use it while waiting for the test result, without affecting the main study comparison.
Anxiety and well-being are not reassessed at the two-week follow-up because participants' emotional responses may be strongly influenced by the amniocentesis result, especially if the result is abnormal. The later follow-up therefore focuses on clinical information and the use of STOP-4P rather than on evaluating its main anxiety-reduction effect.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- The study includes two parallel randomized groups and one additional non-randomized observational comparison group. Participants in all three groups are stratified by clinical indication for amniocentesis. Participants in the randomized component are assigned 1:1 to the STOP-4P or control group, while the observational group is enrolled separately during prespecified study sessions.
| Arm | Type | Receives |
|---|---|---|
| STOP-4P With Video and Supportive Activities | Experimental | Behavioral: STOP4PParticipants receive routine care, watch a short informational video about amniocentesis, complete simple supportive activities, and practice the web-based STOP-4P intervention before amniocentesis. |
| Video and Supportive Activities Without STOP-4P | Other | Behavioral: Informational Video and Supportive ActivitiesParticipants receive routine care, watch the same informational video about amniocentesis, and complete the same supportive activities as the STOP-4P group, but do not practice STOP-4P before amniocentesis. |
| Routine Care Only | No intervention | –Participants receive routine care only before the main post-procedure assessment and do not receive the study video, supportive activities, or STOP-4P during this period. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant women in the second trimester who are scheduled to undergo diagnostic amniocentesis at Hung Vuong Hospital.
- Able to read and understand Vietnamese, complete the study questionnaires, and follow study instructions.
- Willing to participate and provide written informed consent after receiving a full explanation of the study.
Key exclusion criteria (4 listed)
- Previous diagnosis of a psychiatric disorder, such as generalized anxiety disorder, major depression, or schizophrenia.
- Current use of psychiatric medication or receipt of psychological intervention during the current pregnancy.
- Unable to understand or complete the study questionnaires because of cognitive limitations.
- Obstetric emergency at the time of enrollment.
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 |
|---|---|---|
| STOP4PSTOP-4P is a brief, web-based psychological intervention delivered in an interactive, game-like format and completed in about 10 minutes. It includes eight steps: (1) rating the current emotional state on a 1-10 scale; (2) tapping a virtual bell as a cue to stop and pause briefly; (3) practicing slow breathing with a longer exhalation; (4) noticing areas of discomfort or tension in the body, then relaxing the whole body from head to toe; (5) identifying the current emotion by selecting the closest match from six basic emotions; (6) noticing a worrying thought and imagining letting it go; (7) reconnecting with the baby and writing a short loving message to the baby; and (8) rating the emotional state again on the same 1-10 scale. Participants complete STOP-4P while waiting for amniocentesis. | Behavioural | STOP-4P With Video and Supportive Activities |
| Informational Video and Supportive ActivitiesParticipants watch a short informational video explaining the amniocentesis procedure. They then write a wish for their baby to place on the "Wish Tree" and create a card for themselves or their baby. These brief activities are intended to provide information and supportive emotional expression before amniocentesis. | Behavioural | Video and Supportive Activities Without STOP-4P |
Primary outcome
Changes in State and Trait Anxiety Scores Before and After Amniocentesis
Time frame: From the waiting period before amniocentesis to 30 minutes after amniocentesis.
Anxiety is assessed using the 10-item short form of the State-Trait Anxiety Inventory (STAI). It includes two five-item subscales: state anxiety (STAIS-5) and trait anxiety (STAIT-5). Each subscale has a score range of 5 to 20, with higher scores indicating greater anxiety. Both subscales are scored before amniocentesis and 30 minutes after the procedure. For each subscale, the change is calculated as the score after the procedure minus the score before the procedure. A negative change indicates a decrease in anxiety. Changes in state and trait anxiety scores will be compared separately among the STOP-4P, control, and observational groups.
3 secondary outcomes
Well-being Scores Before and After Amniocentesis
Time frame: During the waiting period before amniocentesis and 30 minutes after amniocentesis.
Pain Intensity After Amniocentesis Measured by the Visual Analog Scale
Time frame: 30 minutes after amniocentesis
Changes in Heart Rate and Blood Pressure at Three Time Points
Time frame: During the waiting period before amniocentesis; when the participant gets onto the procedure table; and 30 minutes after amniocentesis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- BackgroundCantril H. The pattern of human concerns. New Brunswick (NJ): Rutgers University Press; 1965.
- BackgroundCohen J. Statistical power analysis for the behavioral sciences. 2nd ed. Hillsdale (NJ): Lawrence Erlbaum Associates; 1988.
- Background: PubMed 37063628Raju NN, Naga Pavan Kumar KSVR, Nihal G. Clinical Practice Guidelines for Assessment and Management of Anxiety and Panic Disorders in Emergency Setting. Indian J Psychiatry. 2023 Feb;65(2):181-185. doi: 10.4103/indianjpsychiatry.indianjpsychiatry_489_22. Epub 2023 Jan 30. No abstract available.
- Background: PubMed 22588748Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.
- BackgroundĐinh Quang Hải, Nguyễn Hoài Bắc. Đặc điểm rối loạn lo âu trên thang điểm STAI-5 ở người bệnh viêm tinh hoàn, mào tinh hoàn điều trị nội trú tại Bệnh viện Đại học Y Hà Nội. Tạp chí Nghiên cứu Y học. 2024;185(12):121-128. doi:10.52852/tcncyh.v185i12.2818.
- Background: PubMed 32563747Zsido AN, Teleki SA, Csokasi K, Rozsa S, Bandi SA. Development of the short version of the spielberger state-trait anxiety inventory. Psychiatry Res. 2020 Sep;291:113223. doi: 10.1016/j.psychres.2020.113223. Epub 2020 Jun 12.
- BackgroundSpielberger CD, Gorsuch RL, Lushene RE. Manual for the State-Trait Anxiety Inventory. Palo Alto (CA): Consulting Psychologists Press; 1970.
- Background: PubMed 36402944Leutenegger V, Grylka-Baeschlin S, Wieber F, Daly D, Pehlke-Milde J. The effectiveness of skilled breathing and relaxation techniques during antenatal education on maternal and neonatal outcomes: a systematic review. BMC Pregnancy Childbirth. 2022 Nov 19;22(1):856. doi: 10.1186/s12884-022-05178-w.
- BackgroundBandura A. Self-efficacy: the exercise of control. New York: W.H. Freeman; 1997.
- Background: PubMed 36111435Rooney T, Sharpe L, Todd J, Richmond B, Colagiuri B. The relationship between expectancy, anxiety, and the nocebo effect: a systematic review and meta-analysis with recommendations for future research. Health Psychol Rev. 2023 Dec;17(4):550-577. doi: 10.1080/17437199.2022.2125894. Epub 2022 Oct 7.
- Background: PubMed 28321201Corsi N, Colloca L. Placebo and Nocebo Effects: The Advantage of Measuring Expectations and Psychological Factors. Front Psychol. 2017 Mar 6;8:308. doi: 10.3389/fpsyg.2017.00308. eCollection 2017.
- Background: PubMed 25343848Woolhouse H, Mercuri K, Judd F, Brown SJ. Antenatal mindfulness intervention to reduce depression, anxiety and stress: a pilot randomised controlled trial of the MindBabyBody program in an Australian tertiary maternity hospital. BMC Pregnancy Childbirth. 2014 Oct 25;14:369. doi: 10.1186/s12884-014-0369-z.
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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.
Thong V Nguyen principal investigator
Hung Vuong Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STOP4P and Informational Video and Supportive Activities in people with Anxiety, run by Hung Vuong Hospital at 1 site in Vietnam.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 25 Sep 2026. 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 Vietnam. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thong V Nguyen (+84 903194666, bsngvanthong@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in State and Trait Anxiety Scores Before and After Amniocentesis (time frame: From the waiting period before amniocentesis to 30 minutes after amniocentesis.). 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 NCT07835464, which also lists 78 linked publications.
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 25 Sep 2026.