Healing Touch After Cesarean
Primary Purpose
Pain, Postoperative, Anxiety, Postpartum Complication
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healing Touch
Control
Sponsored by

About this trial
This is an interventional prevention trial for Pain, Postoperative focused on measuring Healing Touch
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 -
Sites / Locations
- Inova Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Healing Touch
Control
Arm Description
Subjects in this arm get a HT session post cesarean
Subjects in this arm get a control activity of equal duration
Outcomes
Primary Outcome Measures
Pain
1-10 scale
Anxiety
likert scale
Secondary Outcome Measures
Full Information
NCT ID
NCT05053360
First Posted
September 16, 2021
Last Updated
April 17, 2023
Sponsor
Inova Health Care Services
1. Study Identification
Unique Protocol Identification Number
NCT05053360
Brief Title
Healing Touch After Cesarean
Official Title
Effects of Healing Touch on Pain and Anxiety in Women After Cesarean
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 17, 2021 (Actual)
Primary Completion Date
April 14, 2023 (Actual)
Study Completion Date
April 14, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inova Health Care Services
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Rationale: Pain and anxiety are the most common complications after cesarean birth. Pain and anxiety can 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).
Objectives: Primary outcomes will include the differences between the intervention and control groups' pre-/post-intervention levels of pain (Numeric Rating Scale) and anxiety (Numeric Rating scale). Secondary outcomes include the relationship between HT and demographic information of the subjects. As well, the feasibility of introducing HT as a therapy for postpartum women will be assessed.
Study Type: 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 having a scheduled cesarean delivery at Inova Loudoun Hospital (ILH), Inova Fair Oaks Hospital (IFOH), Inova Alexandria Hospital (IAH), and Inova Fairfax Medical Campus (IFMC) who will be enrolled prior to their scheduled cesarean delivery. Inclusion criteria for the HT group are (1) the ability to ensure informed consent and completion of study assessments; (2) the ability to speak, read, and understand English; (3) scheduled cesarean delivery; (4) ≥18 years of age. Exclusion criteria for the HT group are (1) Non-English speaking due to the fidelity and variability of the research (2) Prisoners, (3) Isolation precautions, (4) active psychosis and impaired cognition, and (5) cesarean delivery who delivers prior to scheduled cesarean date. The study is expected to last about one year from study initiation through analysis.
Study Methodology: One to two weeks prior to a scheduled cesarean delivery, a member of the research team will call and screen women for eligibility on the study. If the woman electronically completes the consent form, they will be enrolled in the study and randomized into either the intervention or control group. 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, and complete demographic information from the participant's medical chart. For the intervention group, the HT practitioner will verify consent, then ask the woman to complete baseline measurements of pain and anxiety. The practitioner will administer the HT intervention. Levels of pain and anxiety will be reassessed post-intervention. For the control group: a member of the research team, will ask the woman to complete baseline measurements of pain and anxiety. The subject will then be encouraged to have 15 minutes of quiet time, with the lights dimmed. After the 15 minutes of quite time, the team member will again measure the subject's levels of pain and anxiety.
Statistical Methodology: Descriptive and inferential statistical techniques will be used to determine differences between the intervention and control groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Anxiety, Postpartum Complication
Keywords
Healing Touch
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healing Touch
Arm Type
Experimental
Arm Description
Subjects in this arm get a HT session post cesarean
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Subjects in this arm get a control activity of equal duration
Intervention Type
Behavioral
Intervention Name(s)
Healing Touch
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Other Intervention Name(s)
Quiet Time
Intervention Description
Quiet Time (QT) session is when a subject is provided with quiet for 15 minutes
Primary Outcome Measure Information:
Title
Pain
Description
1-10 scale
Time Frame
Immediately following intervention
Title
Anxiety
Description
likert scale
Time Frame
Immediately following intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaimee Robinson, MSN
Organizational Affiliation
Inova Health Care Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inova Health System
City
Leesburg
State/Province
Virginia
ZIP/Postal Code
20147
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Healing Touch After Cesarean
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