N/A
N=210
Healing Touch After Cesarean
Pain, Postoperative · Anxiety · Postpartum Complication
Bottom Line
View on ClinicalTrials.gov: NCT05053360 ↗Enrolled (actual)
210
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Count of Participants Who Reported HIGH PAIN After the Intervention — 2; 7 Participants — p=.019
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Healing Touch (Behavioral); Control (Other)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Inova Health Care Services
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Count of Participants Who Reported HIGH PAIN After the Intervention |
2; 7 | .019 sig |
| PRIMARY Anxiety Measures After Intervention or Control Activity |
18.8; 20.4 | .0002 sig |
Summary
Pain and anxiety are the most common complications after cesarean birth, and impair the mother's ability to optimally care for herself and her newborn. It is important for health care providers to evaluate options post-operatively to maximize symptom management and quality of care for these patients, including the option of complementary therapies such as Healing Touch (HT). This study examines the effects of HT after cesarean delivers , including the differences between pain (Numeric Rating Scale) and anxiety (Numeric Rating scale) through a Randomized Control Trial study design. The total sample size for the proposed study will include 160 participants. The study will include patients' age ≥18 years. Based on their randomization, the study coordinator at each site will schedule either 1) a Healing Touch (HT) practitioner for the intervention group OR 2) a non-HT practitioner who will collect data for the control group. HT practitioner will verify consent, then ask the woman to complete baseline measurements of pain and anxiety. Levels of pain and anxiety will be reassessed post-intervention.
Eligibility Criteria
Inclusion Criteria
- the ability to ensure informed consent and completion of study assessments
- the ability to speak, read, and understand English
- scheduled cesarean delivery
- ≥18 years of age
Exclusion Criteria
- Non-English speaking due to the fidelity and variability of the research
- Prisoners
- Isolation precautions
- active psychosis and impaired cognition
- cesarean delivery who delivers prior to scheduled cesarean date -
Data sourced from ClinicalTrials.gov (NCT05053360). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.