Healing Touch After Cesarean
Condition: Pain, Postoperative; Anxiety; Postpartum Complication
MeSH terms: Pain, Postoperative
Study type: Interventional

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.
    

Intervention name(s): Healing Touch; Control
Intervention type(s): Behavioral; Other
Intervention description(s): 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.; Quiet Time (QT) session is when a subject is provided with quiet for 15 minutes
Other intervention name(s): Quiet Time
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Healing Touch