Maternal AnxietySBCHNCT07872618
Effect of Spiritual-Based Clinical Hypnotherapy on Maternal Anxiety and Infant Weight Gain
A study testing Spiritual-Based Clinical Hypnotherapy and Guided Spiritual Care in people with Maternal Anxiety, run by Hasanuddin University at 1 site in Indonesia.
Trial summary
This randomized controlled study evaluates whether spiritual-based clinical hypnotherapy can reduce anxiety among breastfeeding mothers and whether changes in maternal anxiety are associated with infant weight gain. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Maternal Anxiety
- What is being tested?
- Spiritual-Based Clinical Hypnotherapy and Guided Spiritual Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Apr 2025to 1 Jun 2026
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Breastfeeding mothers with infants aged 0-6 months who had mild to moderate anxiety based on the Hamilton Anxiety Rating Scale (HARS) and were willing to provide informed consent.
Who cannot join
- Mothers with a history of severe psychiatric disorders or current use of psychotropic medications, and mothers whose infants had congenital abnormalities or growth disorders.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Watampone Primary Health Center and Biru Primary Health Center in urban areas, and Bajoe Primary Health Center in a coastal area
Makassar, South Sulawesi, 90245
About this study
Official title: Effect of Spiritual-Based Clinical Hypnotherapy on Maternal Anxiety and Infant Weight Gain Among Breastfeeding Mothers: A Randomized Controlled Study
This randomized controlled study evaluates whether spiritual-based clinical hypnotherapy can reduce anxiety among breastfeeding mothers and whether changes in maternal anxiety are associated with infant weight gain. The study includes 50 breastfeeding mothers with infants aged 0-6 months who have mild to moderate anxiety. Participants are randomly assigned to either an intervention group receiving spiritual-based clinical hypnotherapy or a control group receiving guided spiritual care without hypnotherapy. The intervention is provided twice weekly for eight weeks, with each session lasting approximately 45-60 minutes. Maternal anxiety is assessed using the Hamilton Anxiety Rating Scale (HARS) before and after the intervention, while infant weight is measured at baseline and after a two-month follow-up period. The study is conducted at three primary healthcare centers in Bone District, South Sulawesi, Indonesia.
Read the detailed description
This randomized controlled study investigates whether spiritual-based clinical hypnotherapy can reduce anxiety in breastfeeding mothers and explores the relationship between maternal anxiety changes and infant weight gain.
Participants and allocation: Fifty breastfeeding mothers with infants aged 0-6 months and mild to moderate anxiety according to the Hamilton Anxiety Rating Scale (HARS) are enrolled after providing informed consent. Participants are allocated by a simple lottery procedure to either the hypnotherapy group (n=25) or the control group (n=25). Blinding of participants is not feasible because of the nature of the intervention. Mothers with severe psychiatric disorders or current psychotropic medication use, and infants with congenital abnormalities or growth disorders, are excluded.
Intervention and comparator: The intervention consists of structured spiritual-based clinical hypnotherapy administered by a certified therapist twice weekly for eight weeks. Each session lasts approximately 45-60 minutes and incorporates relaxation induction, therapeutic suggestions for anxiety management, and guided dhikr. The control group receives guided dhikr without hypnotherapy, facilitated by an experienced religious practitioner.
Outcomes: Maternal anxiety is measured with the 14-item HARS (score range 0-56) at baseline and after the intervention. Infant weight is recorded using calibrated scales, and weight gain is calculated from the difference between baseline and two-month follow-up measurements.
Setting: The study is conducted at Watampone, Biru, and Bajoe Primary Health Centers in Bone District, South Sulawesi, Indonesia.
Analysis: Between-group baseline characteristics are assessed using chi-square or Fisher's exact tests. Repeated-measures ANOVA is used to examine changes in anxiety over time and the time-by-group interaction. Pearson correlation is used to assess the relationship between anxiety reduction and infant weight gain. Exploratory analyses include stratified linear regression and categorization of anxiety reduction. Complete-case analysis is performed, with statistical significance defined as p<0.05.
Ethics: Ethical approval was granted by the Ethics Committee of the Faculty of Public Health, Universitas Hasanuddin (Approval No. 431/UN4.14.1/TP.01.02/2025; March 4, 2025). Written informed consent is obtained from all participants.
- Conditions
- Maternal Anxiety
- Being tested
- Spiritual-Based Clinical Hypnotherapy, Guided Spiritual Care
- Keywords
- maternal anxiety, Breastfeeding mothers, Spiritual-based clinical hypnotherapy, Clinical hypnotherapy, Spiritual care, Dhikr, Infant weight gain, Hamilton Anxiety Rating Scale, Postpartum mental health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spiritual-Based Clinical HypnotherapyBehavioural
Spiritual-based clinical hypnotherapy delivered by a certified therapist twice weekly for eight weeks. Each session lasts approximately 45-60 minutes and consists of relaxation induction, therapeutic suggestions for anxiety regulation, and guided dhikr.
Guided Spiritual CareBehavioural
Guided dhikr without hypnotherapy, facilitated by an experienced religious practitioner, twice weekly for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| Spiritual-Based Clinical Hypnotherapy | Experimental | Spiritual-based clinical hypnotherapy delivered by a certified therapist twice weekly for eight weeks. Each session lasts approximately 45-60 minutes and consists of relaxation induction, therapeutic suggestions for anxiety regulation, and guided dhikr. Receives: Behavioral: Spiritual-Based Clinical Hypnotherapy |
| Guided Spiritual Care | Active comparator | Guided dhikr without hypnotherapy, facilitated by an experienced religious practitioner, twice weekly for eight weeks. Receives: Behavioral: Guided Spiritual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Anxiety Score (HARS)
Maternal anxiety was assessed using the Hamilton Anxiety Rating Scale (HARS), a clinician-administered 14-item instrument with a total score ranging from 0 to 56. Anxiety was assessed at baseline and post-intervention, and the change in HARS score was calculated.
Measured: Baseline and post-intervention (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Apr 2025
- Primary completion27 May 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Musfira, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872618
- Sponsor's protocol ID
- 431/UN4.14.1/TP.01.02/2025
- Acronym
- SBCH
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 13 Oct 2026
- 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Spiritual-Based Clinical Hypnotherapy on Maternal Anxiety and Infant Weight Gain Among Breastfeeding Mothers: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07872618
- Acronym / sponsor ID
- SBCH / 431/UN4.14.1/TP.01.02/2025
- Conditions
- Maternal Anxiety
- Keywords
- maternal anxiety, Breastfeeding mothers, Spiritual-based clinical hypnotherapy, Clinical hypnotherapy, Spiritual care, Dhikr, Infant weight gain, Hamilton Anxiety Rating Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 27 May 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 13 Oct 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.
This randomized controlled study evaluates whether spiritual-based clinical hypnotherapy can reduce anxiety among breastfeeding mothers and whether changes in maternal anxiety are associated with infant weight gain. The study includes 50 breastfeeding mothers with infants aged 0-6 months who have mild to moderate anxiety. Participants are randomly assigned to either an intervention group receiving spiritual-based clinical hypnotherapy or a control group receiving guided spiritual care without hypnotherapy. The intervention is provided twice weekly for eight weeks, with each session lasting approximately 45-60 minutes. Maternal anxiety is assessed using the Hamilton Anxiety Rating Scale (HARS) before and after the intervention, while infant weight is measured at baseline and after a two-month follow-up period. The study is conducted at three primary healthcare centers in Bone District, South Sulawesi, Indonesia.
Detailed description
This randomized controlled study investigates whether spiritual-based clinical hypnotherapy can reduce anxiety in breastfeeding mothers and explores the relationship between maternal anxiety changes and infant weight gain.
Participants and allocation: Fifty breastfeeding mothers with infants aged 0-6 months and mild to moderate anxiety according to the Hamilton Anxiety Rating Scale (HARS) are enrolled after providing informed consent. Participants are allocated by a simple lottery procedure to either the hypnotherapy group (n=25) or the control group (n=25). Blinding of participants is not feasible because of the nature of the intervention. Mothers with severe psychiatric disorders or current psychotropic medication use, and infants with congenital abnormalities or growth disorders, are excluded.
Intervention and comparator: The intervention consists of structured spiritual-based clinical hypnotherapy administered by a certified therapist twice weekly for eight weeks. Each session lasts approximately 45-60 minutes and incorporates relaxation induction, therapeutic suggestions for anxiety management, and guided dhikr. The control group receives guided dhikr without hypnotherapy, facilitated by an experienced religious practitioner.
Outcomes: Maternal anxiety is measured with the 14-item HARS (score range 0-56) at baseline and after the intervention. Infant weight is recorded using calibrated scales, and weight gain is calculated from the difference between baseline and two-month follow-up measurements.
Setting: The study is conducted at Watampone, Biru, and Bajoe Primary Health Centers in Bone District, South Sulawesi, Indonesia.
Analysis: Between-group baseline characteristics are assessed using chi-square or Fisher's exact tests. Repeated-measures ANOVA is used to examine changes in anxiety over time and the time-by-group interaction. Pearson correlation is used to assess the relationship between anxiety reduction and infant weight gain. Exploratory analyses include stratified linear regression and categorization of anxiety reduction. Complete-case analysis is performed, with statistical significance defined as p<0.05.
Ethics: Ethical approval was granted by the Ethics Committee of the Faculty of Public Health, Universitas Hasanuddin (Approval No. 431/UN4.14.1/TP.01.02/2025; March 4, 2025). Written informed consent is obtained from all participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spiritual-Based Clinical Hypnotherapy | Experimental | Behavioral: Spiritual-Based Clinical HypnotherapySpiritual-based clinical hypnotherapy delivered by a certified therapist twice weekly for eight weeks. Each session lasts approximately 45-60 minutes and consists of relaxation induction, therapeutic suggestions for anxiety regulation, and guided dhikr. |
| Guided Spiritual Care | Active comparator | Behavioral: Guided Spiritual CareGuided dhikr without hypnotherapy, facilitated by an experienced religious practitioner, twice weekly for eight weeks. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Breastfeeding mothers with infants aged 0-6 months who had mild to moderate anxiety based on the Hamilton Anxiety Rating Scale (HARS) and were willing to provide informed consent.
Key exclusion criteria (1 listed)
- Mothers with a history of severe psychiatric disorders or current use of psychotropic medications, and mothers whose infants had congenital abnormalities or growth disorders.
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 |
|---|---|---|
| Spiritual-Based Clinical HypnotherapySpiritual-based clinical hypnotherapy delivered by a certified therapist twice weekly for eight weeks. Each session lasts approximately 45-60 minutes and consists of relaxation induction, therapeutic suggestions for anxiety regulation, and guided dhikr. | Behavioural | Spiritual-Based Clinical Hypnotherapy |
| Guided Spiritual CareGuided dhikr without hypnotherapy, facilitated by an experienced religious practitioner, twice weekly for eight weeks. | Behavioural | Guided Spiritual Care |
Primary outcome
Maternal Anxiety Score (HARS)
Time frame: Baseline and post-intervention (8 weeks)
Maternal anxiety was assessed using the Hamilton Anxiety Rating Scale (HARS), a clinician-administered 14-item instrument with a total score ranging from 0 to 56. Anxiety was assessed at baseline and post-intervention, and the change in HARS score was calculated.
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 13 Oct 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. 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 Spiritual-Based Clinical Hypnotherapy and Guided Spiritual Care in people with Maternal Anxiety, run by Hasanuddin University at 1 site in Indonesia.
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 1 inclusion and 1 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 13 Oct 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 Indonesia. 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?
Maternal Anxiety Score (HARS) (time frame: Baseline and post-intervention (8 weeks)). 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 13 Oct 2026.