An interventional study of Spiritual-Based Clinical Hypnotherapy and Guided Spiritual Care in Maternal Anxiety, sponsored by Hasanuddin University. Completed at 1 site in Indonesia. Open to female participants. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Hasanuddin University · Not applicable, Interventional, and Treatment
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.
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.
Hasanuddin University is the lead sponsor of 69 studies on the registry; 6 are open to participants now.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Spiritual-Based Clinical Hypnotherapy
Guided dhikr without hypnotherapy, facilitated by an experienced religious practitioner, twice weekly for eight weeks.
Behavioral: Guided Spiritual Care
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 dhikr without hypnotherapy, facilitated by an experienced religious practitioner, twice weekly for eight weeks.
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.
Time frame: Baseline and post-intervention (8 weeks)
Plan to share: No
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Hasanuddin University