Trial Outcomes & Findings for Healing Touch After Cesarean (NCT NCT05053360)

Last Updated: 2024-06-11

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

210 participants

Primary outcome timeframe

Immediately following intervention

Results posted on

2024-06-11

Participant Flow

Participant milestones

Participant milestones
Measure	Healing Touch Subjects in this arm get a HT session post cesarean 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.	Control Subjects in this arm get a control activity of equal duration Control: Quiet Time (QT) session is when a subject is provided with quiet for 15 minutes
Overall Study STARTED	105	105
Overall Study COMPLETED	74	55
Overall Study NOT COMPLETED	31	50

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Healing Touch After Cesarean

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healing Touch n=74 Participants Subjects in this arm get a HT session post cesarean 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.	Control n=55 Participants Subjects in this arm get a control activity of equal duration Control: Quiet Time (QT) session is when a subject is provided with quiet for 15 minutes	Total n=129 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	74 Participants n=5 Participants	55 Participants n=7 Participants	129 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	35 years n=5 Participants	35 years n=7 Participants	35 years n=5 Participants
Sex: Female, Male Female	74 Participants n=5 Participants	55 Participants n=7 Participants	129 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) White	46 Participants n=5 Participants	30 Participants n=7 Participants	76 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment United States	74 participants n=5 Participants	55 participants n=7 Participants	129 participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately following intervention

Outcome measures

Outcome measures
Measure	Healing Touch n=74 Participants Subjects in this arm get a HT session post cesarean 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.	Control n=55 Participants Subjects in this arm get a control activity of equal duration Control: Quiet Time (QT) session is when a subject is provided with quiet for 15 minutes
Count of Participants Who Reported HIGH PAIN After the Intervention	2 Participants	7 Participants

PRIMARY outcome

Timeframe: Immediately following intervention

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

Outcome measures

Outcome measures
Measure	Healing Touch n=74 Participants Subjects in this arm get a HT session post cesarean 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.	Control n=55 Participants Subjects in this arm get a control activity of equal duration Control: Quiet Time (QT) session is when a subject is provided with quiet for 15 minutes
Anxiety Measures After Intervention or Control Activity	18.8 units on a scale Standard Deviation 3.52	20.4 units on a scale Standard Deviation 6.4

Adverse Events

Healing Touch

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jaimee Robinson, Labor and delivery Clinical Nurse Educator

Inova Health System

Phone: 7038586028

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place