Healing Touch After Cesarean

NCT05053360 | Completed Results

• 1 other identifier: U20-11-4312
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Postoperative; Anxiety; Postpartum Complication

Keywords

Healing Touch

Outcome Measures

Primary Outcomes (2)

• Count of Participants Who Reported HIGH PAIN After the Intervention

  Participant were asked to quantify pain using a numeric pain rating scale that range from 1 (no pain) to 10 (worst pain imaginable) Visual Analog Scale: Measures pain intensity. Higher scores indicate higher levels of pain 0-10 High pain = pain between 6-10 on the Visual Analog Scale

  Immediately following intervention

• Anxiety Measures After Intervention or Control Activity

  Change in anxiety before and after Healing Touch was measured using a scale with 16 questions each with a rating of 1-5, with 1=not at all and 5=extremely. The anxiety scores range from 16 to 80. Higher scores on the scale represent higher anxiety Hospital Anxiety Scale: Measures intensity of anxiety. Higher scores indicate higher levels of anxiety 16 Items Answer options 0-14

  Immediately following intervention

Study Arms (2)

Healing Touch

EXPERIMENTAL

Subjects in this arm get a HT session post cesarean

Behavioral: Healing Touch

Control

ACTIVE COMPARATOR

Subjects in this arm get a control activity of equal duration

Other: Control

Interventions

Healing Touch BEHAVIORAL

Healing Touch (HT), with a foundation in holistic nursing, is a gentle therapy that uses touch to promote health and well-being by balancing the human energy system. Healing Touch (HT) is a biofield therapy in which practitioners use their hands in a heart-centered and intentional way to provide energetic balance to support physical, emotional, mental and spiritual health. It is safe for all ages and works in harmony with, is complementary to, and may be integrated with standard medical care. Healing Touch is a collection of standardized, noninvasive techniques that clear, energize, and balance the human and environmental energy fields.

Healing Touch

Control OTHER

Quiet Time (QT) session is when a subject is provided with quiet for 15 minutes

Also known as: Quiet Time

Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Inova Health Care Services: lead

Study Sites (1)

Inova Health System

Leesburg, Virginia, 20147, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Anxiety Disorders

Interventions

Touch

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Jaimee Robinson, Labor and delivery Clinical Nurse Educator
• Organization: Inova Health System

jaimee.robinson@inova.org

7038586028

Study Officials

• Jaimee Robinson, MSN

  Inova Health Care Services

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: September 22, 2021
• Study Start: August 17, 2021
• Primary Completion: April 14, 2023
• Study Completion: April 14, 2023
• Last Updated: June 11, 2024
• Results First Posted: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)