Depression, PostpartumNCT07807462
Effect of Peripartum 40 Hz Audiovisual Stimulation on Postpartum Depression in Women Undergoing Elective Cesarean Section: A Randomized Clinical Trial
A study testing 40 Hz Audiovisual Stimulation in people with Depression, Postpartum, run by The First People's Hospital of Lianyungang at 1 site in China.
Trial summary
Postpartum depression (PPD) is a common mental health condition affecting 10%-30% of new mothers, with serious consequences for both mother and child. Effective prevention is limited by barriers to psychological or pharmacological treatments. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Depression, Postpartum
- What is being tested?
- 40 Hz Audiovisual Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2026to 31 Jul 2027
- 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 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women scheduled for elective cesarean section under combined spinal-epidural anesthesia;
- Age ≥ 18 years;
- Singleton, full-term pregnancy;
- American Society of Anesthesiologists (ASA) physical status II-III.
Who cannot join
- Refusal to sign informed consent;
- Prior or current diagnosis of psychiatric disorders, including major depressive disorder, bipolar disorder, schizophrenia, etc.;
- Preoperative Edinburgh Postnatal Depression Scale (EPDS) score ≥ 13 or presence of suicidal ideation;
- Current use of antidepressants, antipsychotics, or mood stabilizers;
- History of epilepsy or seizure-like episodes (any type);
- Presence of retinal disease, glaucoma, macular degeneration, cataract, or other ocular conditions that may affect light perception or cause abnormal sensitivity to light stimulation;
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- Severe pregnancy complications: severe preeclampsia, HELLP syndrome, severe gestational diabetes mellitus with organ complications, significant placental abruption, or placenta previa with bleeding risk;
- Allergy to spinal anesthetics (ropivacaine, lidocaine, etc.);
- Participation in other interventional studies that may affect psychological status;
- Inability to receive light stimulation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu
Yuhui Shi, 18961329827, shiyuhui1113@163.com
About this study
Postpartum depression (PPD) is a common mental health condition affecting 10%-30% of new mothers, with serious consequences for both mother and child. Effective prevention is limited by barriers to psychological or pharmacological treatments.
This study evaluates whether short-term 40 Hz light and sound stimulation during and immediately after elective cesarean section can reduce PPD risk. The intervention group receives three 30-minute sessions of combined 40 Hz flashing light and pulsed sound (starting after baby delivery, then at 24 and 48 hours postpartum). The control group receives identical non-flickering light and white noise as placebo.The main outcome is the Edinburgh Postnatal Depression Scale score at 42 days postpartum. Secondary outcomes include depression rates, insomnia severity, and anxiety levels.Participants are women aged ≥18 years with single full-term pregnancy scheduled for elective cesarean section. Exclusion criteria include psychiatric disorders, epilepsy, or eye conditions affecting light sensitivity.
If effective, this non-invasive, drug-free intervention could provide a safe and accessible PPD prevention strategy during routine cesarean delivery.
Read the detailed description
This is a single-center, prospective, randomized clinical trial evaluating whether short-term 40 Hz audiovisual stimulation during and after elective cesarean section can prevent postpartum depression. A total of 204 women (aged ≥18 years, singleton full-term pregnancy, ASA II-III) will be enrolled and randomized 1:1 to intervention or placebo control.
The intervention comprises three 30-minute sessions of combined 40 Hz flashing light and pulsed sound: initiated immediately after fetal delivery, then at 24 and 48 hours post-delivery. The control group receives identical-appearing non-flickering light and white noise. All participants receive standardized multimodal analgesia (epidural morphine 2.0 mg + regular acetaminophen) to minimize pain as a confounding variable.
The primary outcome is EPDS score at postpartum day 42. Secondary outcomes include EPDS at day 7, postpartum depression incidence (EPDS ≥ 10), ISI, and GAD-7 scores at days 1, 7, and 42. Sample size is 204 (102 per group), calculated for 80% power to detect a 2.0-point difference in EPDS (α=0.05, two-sided), accounting for 20% attrition.
Randomization uses block design with concealed allocation. Participants, outcome assessors, and data analysts are blinded. Analysis follows ITT principle, using ANCOVA for the primary outcome and linear mixed models for repeated measures. All participants provide written informed consent.
- Conditions
- Depression, Postpartum
- Being tested
- 40 Hz Audiovisual Stimulation, Placebo Audiovisual Stimulation
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40 Hz Audiovisual StimulationDevice
A non-invasive device delivering 40 Hz flickering light (3900-4000K correlated color temperature natural white LED) combined with synchronized 40 Hz pulsed sound . The device is secured to the participant's head via an adjustable headband, with light transmitted through closed eyelids and headphones placed over the ears. Each session lasts 30 minutes.
Placebo Audiovisual StimulationDevice
An identical-appearing non-invasive device delivering continuous non-flickering natural white light (same correlated color temperature 3900-4000K and appearance as the active device) combined with white noise, serving as placebo control. Each session lasts 30 minutes. The device is secured via an adjustable headband with light transmitted through closed eyelids and headphones placed over the ears.
| Study group | Role | What they receive |
|---|---|---|
| 40Hz Audiovisual Stimulation Group | Experimental | Participants receive three 30-minute sessions of combined 40 Hz flashing light (3900-4000K natural white LED) and synchronized 40 Hz pulsed sound. The first session is initiated immediately after fetal delivery; the second session at 24 hours post-delivery; the third session at 48 hours post-delivery. Receives: Device: 40 Hz Audiovisual Stimulation |
| Placebo Control Group | Placebo comparator | Participants receive three 30-minute sessions of continuous non-flickering natural white light (same color temperature and appearance as the intervention device) and white noise as auditory stimulus, serving as placebo control. Receives: Device: Placebo Audiovisual Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edinburgh Postnatal Depression Scale Score at 42 Days Postpartum
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-reported questionnaire. Each item is scored 0-3, total score 0-30. Higher scores indicate more severe depressive symptoms.
Measured: 42 days after delivery
Secondary outcomes (4)
Edinburgh Postnatal Depression Scale Score at 7 Days Postpartum
EPDS total score (0-30) assessed at 7 days after delivery.
Measured: 7 days after delivery
Incidence of Postpartum Depression at 7 and 42 Days
Proportion of participants with EPDS score ≥ 10 at postpartum day 7 and day 42.
Measured: 7 and 42 days after delivery
Insomnia Severity Index Score at 1, 7, and 42 Days
The Insomnia Severity Index (ISI) is a 7-item self-reported questionnaire assessing insomnia severity over the past week. Total score 0-28, higher scores indicate more severe insomnia.
Measured: 1, 7, and 42 days after delivery
Generalized Anxiety Disorder 7-item Scale Score at 1, 7, and 42 Days
The GAD-7 is a 7-item self-reported questionnaire assessing anxiety symptoms. Total score 0-21, higher scores indicate more severe anxiety.
Measured: 1, 7, and 42 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, PostpartumStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Lianyungang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807462
- Sponsor's protocol ID
- KY-20260629006-02
- Status last verified
- Aug 2026
- First submitted
- 2 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Peripartum 40 Hz Audiovisual Stimulation on Postpartum Depression in Women Undergoing Elective Cesarean Section: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07807462
- Acronym / sponsor ID
- KY-20260629006-02
- Conditions
- Depression, Postpartum
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- The First People's Hospital of LianyungangUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 8 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.
Postpartum depression (PPD) is a common mental health condition affecting 10%-30% of new mothers, with serious consequences for both mother and child. Effective prevention is limited by barriers to psychological or pharmacological treatments.
This study evaluates whether short-term 40 Hz light and sound stimulation during and immediately after elective cesarean section can reduce PPD risk. The intervention group receives three 30-minute sessions of combined 40 Hz flashing light and pulsed sound (starting after baby delivery, then at 24 and 48 hours postpartum). The control group receives identical non-flickering light and white noise as placebo.The main outcome is the Edinburgh Postnatal Depression Scale score at 42 days postpartum. Secondary outcomes include depression rates, insomnia severity, and anxiety levels.Participants are women aged ≥18 years with single full-term pregnancy scheduled for elective cesarean section. Exclusion criteria include psychiatric disorders, epilepsy, or eye conditions affecting light sensitivity.
If effective, this non-invasive, drug-free intervention could provide a safe and accessible PPD prevention strategy during routine cesarean delivery.
Detailed description
This is a single-center, prospective, randomized clinical trial evaluating whether short-term 40 Hz audiovisual stimulation during and after elective cesarean section can prevent postpartum depression. A total of 204 women (aged ≥18 years, singleton full-term pregnancy, ASA II-III) will be enrolled and randomized 1:1 to intervention or placebo control.
The intervention comprises three 30-minute sessions of combined 40 Hz flashing light and pulsed sound: initiated immediately after fetal delivery, then at 24 and 48 hours post-delivery. The control group receives identical-appearing non-flickering light and white noise. All participants receive standardized multimodal analgesia (epidural morphine 2.0 mg + regular acetaminophen) to minimize pain as a confounding variable.
The primary outcome is EPDS score at postpartum day 42. Secondary outcomes include EPDS at day 7, postpartum depression incidence (EPDS ≥ 10), ISI, and GAD-7 scores at days 1, 7, and 42. Sample size is 204 (102 per group), calculated for 80% power to detect a 2.0-point difference in EPDS (α=0.05, two-sided), accounting for 20% attrition.
Randomization uses block design with concealed allocation. Participants, outcome assessors, and data analysts are blinded. Analysis follows ITT principle, using ANCOVA for the primary outcome and linear mixed models for repeated measures. All participants provide written informed consent.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 40Hz Audiovisual Stimulation Group | Experimental | Device: 40 Hz Audiovisual StimulationParticipants receive three 30-minute sessions of combined 40 Hz flashing light (3900-4000K natural white LED) and synchronized 40 Hz pulsed sound. The first session is initiated immediately after fetal delivery; the second session at 24 hours post-delivery; the third session at 48 hours post-delivery. |
| Placebo Control Group | Placebo comparator | Device: Placebo Audiovisual StimulationParticipants receive three 30-minute sessions of continuous non-flickering natural white light (same color temperature and appearance as the intervention device) and white noise as auditory stimulus, serving as placebo control. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women scheduled for elective cesarean section under combined spinal-epidural anesthesia;
- Age ≥ 18 years;
- Singleton, full-term pregnancy;
- American Society of Anesthesiologists (ASA) physical status II-III.
Key exclusion criteria (10 listed)
- Refusal to sign informed consent;
- Prior or current diagnosis of psychiatric disorders, including major depressive disorder, bipolar disorder, schizophrenia, etc.;
- Preoperative Edinburgh Postnatal Depression Scale (EPDS) score ≥ 13 or presence of suicidal ideation;
- Current use of antidepressants, antipsychotics, or mood stabilizers;
- History of epilepsy or seizure-like episodes (any type);
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 |
|---|---|---|
| 40 Hz Audiovisual StimulationA non-invasive device delivering 40 Hz flickering light (3900-4000K correlated color temperature natural white LED) combined with synchronized 40 Hz pulsed sound . The device is secured to the participant's head via an adjustable headband, with light transmitted through closed eyelids and headphones placed over the ears. Each session lasts 30 minutes. | Device | 40Hz Audiovisual Stimulation Group |
| Placebo Audiovisual StimulationAn identical-appearing non-invasive device delivering continuous non-flickering natural white light (same correlated color temperature 3900-4000K and appearance as the active device) combined with white noise, serving as placebo control. Each session lasts 30 minutes. The device is secured via an adjustable headband with light transmitted through closed eyelids and headphones placed over the ears. | Device | Placebo Control Group |
Primary outcome
Edinburgh Postnatal Depression Scale Score at 42 Days Postpartum
Time frame: 42 days after delivery
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-reported questionnaire. Each item is scored 0-3, total score 0-30. Higher scores indicate more severe depressive symptoms.
4 secondary outcomes
Edinburgh Postnatal Depression Scale Score at 7 Days Postpartum
Time frame: 7 days after delivery
Incidence of Postpartum Depression at 7 and 42 Days
Time frame: 7 and 42 days after delivery
Insomnia Severity Index Score at 1, 7, and 42 Days
Time frame: 1, 7, and 42 days after delivery
Generalized Anxiety Disorder 7-item Scale Score at 1, 7, and 42 Days
Time frame: 1, 7, and 42 days after delivery
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 8 Sep 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 40 Hz Audiovisual Stimulation in people with Depression, Postpartum, run by The First People's Hospital of Lianyungang at 1 site in China.
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 4 inclusion and 10 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 8 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 China. 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. Some participants in this study may receive a placebo. 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 Xiaobao Zhang (18961322507, hotdog100@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edinburgh Postnatal Depression Scale Score at 42 Days Postpartum (time frame: 42 days after delivery). 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 8 Sep 2026.