Clinical trial NCT05053360: Healing Touch After Cesarean
Official title: Effects of Healing Touch on Pain and Anxiety in Women After Cesarean
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Anxiety
Postpartum Complication
Keywords: Healing Touch
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 210
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 -

Primary outcomes:
measure: Count of Participants Who Reported HIGH PAIN After the Intervention
timeFrame: Immediately following intervention
measure: Anxiety Measures After Intervention or Control Activity
timeFrame: Immediately following intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Leesburg
country: United States
facility: Inova Health System
state: Virginia
Study officials:
affiliation: Inova Health Care Services
name: Jaimee Robinson, MSN
role: PRINCIPAL_INVESTIGATOR
References: