Healing Touch After Cesarean

NCT ID: NCT05053360

Last Updated: 2024-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-17
• Study Completion Date: 2023-04-14

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.

Conditions

Pain, Postoperative; Anxiety; Postpartum Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Healing Touch

Subjects in this arm get a HT session post cesarean

Group Type: EXPERIMENTAL

Healing Touch

Intervention Type: 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.

Control

Subjects in this arm get a control activity of equal duration

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

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

Interventions

Healing Touch

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: BEHAVIORAL

Control

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

Intervention Type: OTHER

Other Intervention Names

Quiet Time

Eligibility Criteria

Inclusion Criteria

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

1. Non-English speaking due to the fidelity and variability of the research

2. Prisoners

3. Isolation precautions

4. active psychosis and impaired cognition

5. cesarean delivery who delivers prior to scheduled cesarean date -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Inova Health Care Services

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jaimee Robinson, MSN

Role: PRINCIPAL_INVESTIGATOR

Inova Health Care Services

Locations

Inova Health System

Leesburg, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

U20-11-4312

Identifier Type: -

Identifier Source: org_study_id