An interventional study of Triple Combination and Breastfeeding (Tetanalgesia) in PAIN and PAIN MANAGEMENT, sponsored by Universitat Jaume I. Completed at 1 site in Spain. Open to participants aged 47 Hours to 52 Hours. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Universitat Jaume I · Not applicable, Interventional, and Supportive care
Among 341 studies in Pain with a site in Spain — 58 open to participants now, 68 under way, 7 of them phase 3. Pain · Spain.
Among the 341 studies in Pain with a site in Spain, this one is the 75th largest by enrollment of the 295 interventional ones that give a count, is one of 34 that started in 2021, is one of 206 with no phase, and was the 338th registered.
10,060 studies on the registry are indexed under Pain; 1,651 are open to participants now.
Browse Pain studies →58 of the 341 studies in Pain with a site in Spain are open now. Recruiting first, the newest first:
Neuron, Spain · Sites in Spain
Ages 18+ · Healthy volunteers
University Rovira i Virgili · Sites in Spain
Ages 18–40 · Healthy volunteers
European University Miguel de Cervantes · Sites in Spain
Ages 18+ · Women only
Institut Investigacio Sanitaria Pere Virgili · Sites in Spain
Ages 18–50 · Women only
Arafarma Group, S.A. · Sites in Spain
Ages 18+ · Women only
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 929 Pain studies recruiting now, 384 (41%) set no upper age limit and 434 (47%) stop at 75 or younger; 146 take children under 18; 222 take healthy volunteers.
This study: 47 Hours to 52 Hours · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
341 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 29 · Phase 3 47 · Phase 4 17
First in 2001; this study’s year is marked. 34 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 128 is above the median of 66 across 8,497 interventional studies indexed under Pain.
Median enrollment 60 across the 295 interventional studies, 165 across the 46 observational. Of the 245 that completed or were terminated, 37 (15%) have results posted.
This tab as a report to print or save as PDF → With an account.
72 of 341 have an industry lead sponsor. The 10 most frequent:
Universitat Jaume I is the lead sponsor of 80 studies on the registry; 19 are open to participants now.
Universitat Jaume I has 1 study filed under Pain — fewer than ten, so there is no comparison to draw.
7 of the studies in Pain with a site in Spain that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04299893Phase 3Bernardino Clavo, MD, PhDOzone Therapy in Chemotherapy-induced Peripheral Neuropathy: RCT (O3NPIQ) | 2027-09-30 |
| NCT06948500Cardenal Herrera UniversityEffectiveness of an IVR-based Therapeutic Exercise Program With Altered Visual Feedback in Fibromyalgia Patients | 2026-12-01 |
| NCT07694141Hospital Universitario de Gran Canaria Doctor NegrínPostoperative Analgesia in Thoracic Surgery | 2026-12-31 |
| NCT05635929Mucosa Innovations, S.L.Effect of a Novel Topical Composition on the Incidence of Severe Oral Mucositis in Head & Neck Cancer Radiated Patients and Quality of Life Assessed by PROMs. | 2027-03 |
| NCT07741864Hospital Universitario Virgen MacarenaEffectiveness of a Mindfulness-Based Intervention for Pain Management in Patients With Multiple Sclerosis (MPIMS). | 2027-04-30 |
Add all 7 to your calendar (.ics) → With an account.
Among the 341 studies in Pain with a site in Spain, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This randomized clinical trial evaluated whether a non-pharmacological Triple Combination of expressed breast milk, sucking, and facilitated tucking reduced pain during heel prick in healthy term newborns compared with Breastfeeding (Tetanalgesia). The study included healthy term newborns with a gestational age of 37 weeks or more whose parents provided informed consent in the maternity unit of Hospital Comarcal de Vinaròs, Spain. Pain and response to the procedure were assessed by comparing the two groups, and two investigators who were not involved in data collection independently reviewed the video recordings to assign pain scores.
The study was designed as a randomized, single-blind clinical trial with two study groups. Healthy term newborns were recruited consecutively from January 2021 to March 2023 in the maternity unit of Hospital Comarcal de Vinaròs (Castellón, Spain). After informed consent was obtained from parents or legal representatives, participants were allocated by simple randomization using sealed envelopes to one of two study groups: Triple Combination or Breastfeeding (Tetanalgesia).
In the Triple Combination group, neonates were placed in a lateral flexed position with the arms and legs close to the trunk. Sucking with a pacifier or finger was started 2 minutes before the heel prick and continued until 2 minutes after the procedure. During the procedure, 1 to 2 mL of freshly expressed breast milk was administered by syringe, while facilitated tucking was maintained throughout the procedure and for 2 minutes afterward.
In the Breastfeeding (Tetanalgesia) group, neonates were breastfed during the heel prick while being held in their mothers' arms. The procedure started after approximately 2 minutes of effective sucking and ended 2 minutes after the heel prick. Pain outcomes were assessed using the Premature Infant Pain Profile (PIPP) and the Neonatal Infant Pain Scale (NIPS). Additional outcomes included heart rate and oxygen saturation at baseline (at rest), 15 seconds after heel prick, and 30 seconds after heel prick, as well as crying duration in seconds from the start of the heel prick until crying ceased, assessed up to 5 minutes after heel prick. Two independent investigators who were not involved in data collection reviewed the video recordings to assign pain scores.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Participants receive the Triple Combination intervention during heel prick.
Procedure: Triple Combination
Participants receive the Breastfeeding (Tetanalgesia) intervention during heel prick.
Procedure: Breastfeeding (Tetanalgesia)
Triple Combination intervention administered during heel prick.
Breastfeeding (Tetanalgesia) intervention administered during heel prick.
Total score on the Premature Infant Pain Profile (PIPP)
Total score on the Premature Infant Pain Profile (PIPP), assessed in term newborns (gestational age ≥37 weeks) during the heel prick procedure using a 15 second behavioral observation period and a 30 second physiological/facial observation period. Possible scores range from 0 to 18, with higher scores indicating worse pain.
Time frame: During the heel prick procedure.
Total score on the Neonatal Infant Pain Scale (NIPS)
Total score on the Neonatal Infant Pain Scale (NIPS), assessed during the heel prick procedure. The scale evaluates five behavioral responses and one physiological response to procedural pain. Possible scores range from 0 to 7, with higher scores indicating worse pain.
Time frame: During the heel prick procedure.
Time to cessation of crying
Time from the start of the heel prick until cessation of crying, measured in seconds.
Time frame: Up to 5 minutes after heel prick.
Mean heart rate
Mean heart rate, measured in beats per minute, recorded in term newborns (gestational age ≥ 37 weeks) at baseline (at rest), 15 seconds after heel prick, and 30 seconds after heel prick.
Time frame: Baseline (at rest), 15 seconds after heel prick, and 30 seconds after heel prick.
Mean oxygen saturation (SpO2)
Mean oxygen saturation (SpO2), measured as percentage, recorded in term newborns (gestational age ≥37 weeks) at baseline (at rest), 15 seconds after heel prick, and 30 seconds after heel prick.
Time frame: Baseline (at rest), 15 seconds after heel prick, and 30 seconds after heel prick.
Plan to share: No — Individual participant data will not be shared because there is no plan for data sharing and participant confidentiality will be protected.
Ran from Jan 2021 to primary completion in Mar 2023, 25 months.
Of 3,734 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's 25 months is above that.
Counting every sponsor, half of 3,833 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Universitat Jaume I